Cambridge, MA, United States

Philips North America Llc recalls

161 recalls recorded since 2018, most recently on 28 August 2026. 101 are listed as ongoing. Status and classification are as published by the FDA.

Recalls161

Ongoing (FDA)101

Terminated or completed60

Class I (FDA)4

Ongoing Class II Medical devices

Recall started: 28 August 2026
Reason: When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Distribution: Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Gree
Initiated: Voluntary: Firm initiated
Recall numbers: Z-3309-2026, Z-3313-2026, Z-3308-2026, Z-3318-2026, Z-3316-2026, Z-3312-2026, Z-3315-2026, Z-3307-2026, Z-3310-2026, Z-3311-2026, Z-3317-2026, Z-3314-2026

Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T CX); Software Versions: R11, R12 and R13;
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13;
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T), 4. 782115 (1.5T), 5. 782140 (1.5T), 6. 781262 (1.5T CX), 7. 781347 (1.5T S); Software Versions: R11, R12 and
Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782166 (1.5T), 4. 782201(1.5T), 5. 782117 (3.0T), 6. 782143 (3.0T), 7. 782162 (3.0T); Software Versions: R1
Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software Versions: R11, R12 and R13;
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;
Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
and 4 more product lines

Ongoing Class II Medical devices

Recall started: 21 August 2026
Reason: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'
Initiated: Voluntary: Firm initiated
Recall numbers: Z-3233-2026, Z-3239-2026, Z-3242-2026, Z-3241-2026, Z-3236-2026, Z-3234-2026, Z-3235-2026, Z-3238-2026, Z-3240-2026, Z-3237-2026, Z-3232-2026, Z-3243-2026

Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);
MR 5300 Model Number (REF): 1. 782110, 2. 782152;
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 781262(1.5T CX), 9. 781
Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);
and 4 more product lines

Ongoing Class II Medical devices

Recall started: 18 August 2026
Reason: The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
Distribution: U.S. and U.S. Territories.
Initiated: FDA Mandated
Recall number: Z-3155-2026

Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333

Ongoing Class II Medical devices

Recall started: 7 August 2026
Reason: Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Distribution: US and US Territories.
Initiated: FDA Mandated
Recall numbers: Z-3043-2026, Z-3042-2026, Z-3041-2026, Z-3040-2026

Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.

Ongoing Class II Medical devices

Recall started: 31 July 2026
Reason: Due to software malfunction, patient information system may freeze and become unresponsive.
Distribution: Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the cou
Initiated: Voluntary: Firm initiated
Recall numbers: Z-3142-2026, Z-3141-2026

Philips PIC iX Essentials REF:867093
Philips Patient Information Center iX REF:866389

Ongoing Class II Medical devices

Recall started: 1 July 2026
Reason: Device will intermittently provide inaccurate data related to native heart rate.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, France, Germany, Gibraltar, Hong Kong, Iceland, Ireland, Iraq, Italy, Luxembourg, Malta, Netherlands, New Caledonia, New Zealand, Norway, Pol
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2955-2026, Z-2956-2026

Cardiac Workstation 5000. Product Number: 860439.
Cardiac Workstation 7000. Product Number: 860441.

Ongoing Class II Medical devices

Recall started: 5 June 2026
Reason: Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
Distribution: US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN.
Initiated: Voluntary: Firm initiated
Recall number: Z-2579-2026

Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.

Ongoing Class II Medical devices

Recall started: 26 May 2026
Reason: Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Distribution: Worldwide distribution - US Nationwide and The countries of AE, AT, AU, BE, BG, BH, BR, CA, CH, CN, CR, CZ, DE, ES, FI, FR, GB, GR, HK, ID, IL, IN, IT, JO, JP, KR, KR, LT, LU, LV, MX, MY, NL, NZ, OM, SA, SE, SG, SI, TR, TW, ZA.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2522-2026, Z-2523-2026

Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

Ongoing Class II Medical devices

Recall started: 1 May 2026
Reason: System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
Distribution: US distribution to California.
Initiated: Voluntary: Firm initiated
Recall number: Z-2354-2026

DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.

Ongoing Class II Medical devices

Recall started: 14 April 2026
Reason: The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Distribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlan
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1966-2026, Z-1968-2026, Z-1958-2026, Z-1955-2026, Z-1960-2026, Z-1951-2026, Z-1957-2026, Z-1963-2026, Z-1959-2026, Z-1952-2026, Z-1956-2026, Z-1964-2026 and 7 more

Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K
and 11 more product lines

Ongoing Class II Medical devices

Recall started: 7 January 2026
Reason: As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egy
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1315-2026, Z-1317-2026, Z-1316-2026, Z-1318-2026

Brilliance iCT; Product Code (REF): 728306;
Spectral CT; Product Code (REF): 728333;
IQon Spectral CT; Product Code (REF): 728332;
Spectral CT 7500 on Rails; Product Code (REF): 728334;

Ongoing Class II Medical devices

Recall started: 22 December 2025
Reason: A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Canada, Czech Republic, Dominican Rep, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzer
Initiated: Voluntary: Firm initiated
Recall number: Z-1156-2026

Patient Information Center iX; Software Version Number: 4.5.0

Ongoing Class II Medical devices

Recall started: 12 December 2025
Reason: It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1033-2026

Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.

Ongoing Class II Medical devices

Recall started: 3 December 2025
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, Unite
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1215-2026, Z-1209-2026, Z-1204-2026, Z-1207-2026, Z-1213-2026, Z-1208-2026, Z-1212-2026, Z-1205-2026, Z-1216-2026, Z-1210-2026, Z-1211-2026, Z-1214-2026 and 1 more

SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
and 5 more product lines

Ongoing Class II Medical devices

Recall started: 31 October 2025
Reason: Potential issue where the IntelliVue monitors did not alarm.
Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Botswana, Brazil, Brunei, Bulgaria, Burundi, Cambodia, Canada, Cayman Islands, Chile, China, Co
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0858-2026, Z-0852-2026, Z-0869-2026, Z-0867-2026, Z-0864-2026, Z-0870-2026, Z-0849-2026, Z-0854-2026, Z-0857-2026, Z-0861-2026, Z-0853-2026, Z-0859-2026 and 10 more

IntelliVue MP90. Product Number: M8010A.
IntelliVue MP30. Product Number: M8002A.
IntelliVue Patient Monitor MX800. Product Number: 865240.
IntelliVue Patient Monitor MX700. Product Number: 865241.
IntelliVue Patient Monitor MX500. Product Number: 866064.
IntelliVue Patient Monitor MX850. Product Number: 866470.
IntelliVue MP2. Product Number: M8102A.
IntelliVue MP50. Product Number: M8004A.
and 14 more product lines

Ongoing Class II Medical devices

Recall started: 29 October 2025
Reason: If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Rep
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0882-2026, Z-0881-2026

CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

Ongoing Class II Medical devices

Recall started: 27 October 2025
Reason: Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
Distribution: U.S.
Initiated: FDA Mandated
Recall number: Z-0597-2026

Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

Ongoing Class II Medical devices

Recall started: 12 September 2025
Reason: Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Distribution: US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0165-2026, Z-0166-2026

Cardiac Workstation 5000; Model Number: 860439;
Cardiac Workstation 7000; Model Number: 860441;

Ongoing Class II Medical devices

Recall started: 13 August 2025
Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauriti
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2598-2025, Z-2601-2025, Z-2597-2025, Z-2603-2025, Z-2604-2025, Z-2596-2025, Z-2595-2025, Z-2600-2025, Z-2602-2025, Z-2599-2025

Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317
Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.
and 2 more product lines

Ongoing Class II Medical devices

Recall started: 30 June 2025
Reason: The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cu
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2211-2025, Z-2215-2025, Z-2205-2025, Z-2206-2025, Z-2213-2025, Z-2208-2025, Z-2200-2025, Z-2218-2025, Z-2207-2025, Z-2210-2025, Z-2201-2025, Z-2217-2025 and 7 more

Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);
SmartPath to dStream for 3.0T Model Number (REF): 782145;
Ingenia 1.5T S Model Number (REF): 781347;
Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;
MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
Upgrade to MR 7700 Model Number (REF): 782130;
and 11 more product lines

Ongoing Class II Medical devices

Recall started: 29 May 2025
Reason: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1931-2025, Z-1932-2025, Z-1936-2025, Z-1929-2025, Z-1930-2025, Z-1935-2025, Z-1933-2025, Z-1934-2025, Z-1928-2025

Intera 1.5T Achieva Nova-Dual Product Number: 781173;
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
SmartPath to dStream for 1.5T¿; Product Number: 782146;
Intera 1.5T Achieva IT Nova Product Number: 781175
Intera 1.5T Achieva Nova Product Number: 781172;
Intera Achieva 1.5T Pulsar; Product Number: 781171;
Intera 1.5T Master/Nova Product Number: 781106;
Intera 1.5T Omni/Stellar; Product Number: 781104;
and 1 more product lines

Ongoing Class II Medical devices

Recall started: 29 May 2025
Reason: Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
Distribution: Domestic: AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Macao, Malaysia, Netherlands, New Zeal
Initiated: Voluntary: Firm initiated
Recall number: Z-2034-2025

Spectral CT. Computed tomography X-ray system.

Ongoing Class II Medical devices

Recall started: 13 May 2025
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Distribution: Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ire
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1794-2025, Z-1800-2025, Z-1799-2025, Z-1805-2025, Z-1803-2025, Z-1797-2025, Z-1796-2025, Z-1789-2025, Z-1801-2025, Z-1802-2025, Z-1791-2025, Z-1798-2025 and 6 more

Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Product Name: Ingenia 3.0T CX; Model Number: 781271;
Product Name: Ingenia 1.5T CX; Model Number: 781262;
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
Product Name: Ingenia 1.5T S; Model Number: 781347;
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
and 10 more product lines

Ongoing Class II Medical devices

Recall started: 7 April 2025
Reason: Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
Distribution: Worldwide distribution - US Nationwide and the countries of AE, AL, AO, AR, AT, AU, AW, BD, BE, BG, BH, BO, BR, BW, BY, CA, CD, CH, CI, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, ET, FI, FJ, FO, FR, GA, GB, GF, GH, GI, GP, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KE,
Initiated: Voluntary: Firm initiated
Recall number: Z-1722-2025

Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Ad

Ongoing Class II Medical devices

Recall started: 1 April 2025
Reason: Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
Distribution: Worldwide distribution: US (Nationwide); and OUS (Foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Czech Republic, Estonia, France, Germany, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Lebanon, Libya, Luxembourg,
Initiated: Voluntary: Firm initiated
Recall number: Z-1660-2025

Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

Ongoing Class II Medical devices

Recall started: 10 March 2025
Reason: Potential for collimator to fall as a result of incorrect installation.
Distribution: Worldwide - US Nationwide distribution in the states of AK, FL, KS, MS, NH, NY, OR, PA, TX, WI and the countries of Argentina, Australia, Canada, Chile, China, Germany, Hungary, India, Indonesia, Italy, Kenya, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Poland, Romania, Russian Federatio
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1554-2025, Z-1553-2025

Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

Ongoing Class II Medical devices

Recall started: 25 February 2025
Reason: A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Distribution: US
Initiated: FDA Mandated
Recall numbers: Z-1581-2025, Z-1582-2025, Z-1580-2025

Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within
Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), with
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within

Ongoing Class II Medical devices

Recall started: 15 January 2025
Reason: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Distribution: US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1107-2025, Z-1108-2025, Z-1110-2025, Z-1109-2025, Z-1106-2025

IntelliVue Patient Monitor MX400. Model Number: 866060
IntelliVue Patient Monitor MX450. Model Number: 866062
IntelliVue Patient Monitor MX550. Model Number: 866066
IntelliVue Patient Monitor MX500. Model Number: 866064
IntelliBridge EC10 Module. Model Number: 865115

Ongoing Class II Medical devices

Recall started: 20 November 2024
Reason: The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially causing the client device to appear to drop out from the network. 2. if the Access Point experiences a disconnection from the Access Point Controller exceeding 4 minutes, the Access Point may not transition through the desired state to all for clean reconnection of the client radio link. 3. Potential to experience higher than expected data dropouts, device disassociations/reassociations for their wireless clients, and frequent "Loss of AP" alerts. 4. Potential for the Smart-hopping Access Point is affected by a software issue where the Access Point will resent after 82.85 days when the frame counter reaches its limit. This causes the latest synchronization check to fail and potential for loss of patient data.
Distribution: Nationwide distribution
Initiated: Voluntary: Firm initiated
Recall number: Z-0686-2025

Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216

Ongoing Class II Medical devices

Recall started: 16 November 2024
Reason: Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.
Distribution: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Macao, Malaysia, Net
Initiated: Voluntary: Firm initiated
Recall number: Z-0583-2025

Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.

Ongoing Class II Medical devices

Recall started: 4 November 2024
Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0537-2025, Z-0544-2025, Z-0541-2025, Z-0540-2025, Z-0548-2025, Z-0545-2025, Z-0546-2025, Z-0539-2025, Z-0538-2025, Z-0547-2025, Z-0542-2025, Z-0543-2025 and 1 more

dS Breast 16ch 1.5T
Mammotrak Interventional Coil 3.0T
Mammotrak Diagnostic Coil 1.5T
dS Breast 7ch 3.0T
ST SENSE Breast Dx Coil
SENSE Breast Coil
SENSE Breast Coil 3.0T 7ch
dS Breast 7ch 1.5T
and 5 more product lines

Ongoing Class II Medical devices

Recall started: 3 September 2024
Reason: Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Maldiv
Initiated: Voluntary: Firm initiated
Recall numbers: Z-3195-2024, Z-3197-2024, Z-3196-2024, Z-3193-2024, Z-3204-2024, Z-3200-2024, Z-3203-2024, Z-3198-2024, Z-3194-2024, Z-3205-2024, Z-3199-2024, Z-3201-2024 and 1 more

Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782103
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers:
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 78
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numb
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation.
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers:
SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (R
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 7
and 5 more product lines

Ongoing Class II Medical devices

Recall started: 30 August 2024
Reason: During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.
Distribution: US Nationwide. Global Distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-3249-2024

IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)

Ongoing Class II Medical devices

Recall started: 28 June 2024
Reason: Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
Distribution: Nationwide Foreign: Australia Austria Bangladesh Brazil Canada Chile China Colombia Denmark France Germany Hong Kong India Indonesia Italy Japan Netherlands Portugal Singapore South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand United Kingdom Vietnam
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2510-2024, Z-2508-2024, Z-2509-2024, Z-2511-2024

IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for,
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for,
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for,
IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for,

Ongoing Class I Medical devices

Recall started: 5 June 2024
Reason: Potential for coils to heat up and harm patients (burn).
Distribution: Worldwide distribution: US (Nationwide) and OUS (Foreign): Afghanistan, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Hong Ko
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2163-2024, Z-2164-2024, Z-2165-2024

SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers:
SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils ma
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453

Ongoing Class II Medical devices

Recall started: 22 May 2024
Reason: Potential for inaccurate fetal heart rate measurements when monitoring multiples.
Distribution: Worldwide distribution - US Nationwide and the countries of AD, AE, AR, AT, AU, BA, BE, BG, BH, BO, BR, CH, CL, CO, CY, CZ, DE, DZ, EG, ES, FI, FR, GB, GI, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JP, KE, KW, LB, LK, LS, LT, LU, LV, LY, MA, ME, MT, MU, MY, NA, NI, NL, NZ, OM, PA, PH, PK, PL, PR,
Initiated: Voluntary: Firm initiated
Recall number: Z-2239-2024

Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.

Ongoing Class II Medical devices

Recall started: 3 May 2024
Reason: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailan
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1839-2024, Z-1857-2024, Z-1850-2024, Z-1851-2024, Z-1861-2024, Z-1844-2024, Z-1843-2024, Z-1854-2024, Z-1859-2024, Z-1864-2024, Z-1853-2024, Z-1838-2024 and 18 more

Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483
Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359
Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356
SmartPath to dStream for 3.0T Model Number (REF): 782145
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148
MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110
and 22 more product lines

Ongoing Class II Medical devices

Recall started: 3 May 2024
Reason: Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Fiji, Finland, France, French Guiana, Germany, Guadeloupe, Honduras, Hong Kong, India, Indonesia, Ireland, Italy, J
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1950-2024, Z-1949-2024, Z-1948-2024

HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411

Ongoing Class II Medical devices

Recall started: 22 April 2024
Reason: Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Distribution: Worldwide - US Nationwide distribution in the states of CA, KS, MS, NH and the countries of Austria, Croatia, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Sweden, Switzerland, Thailand, United Kingdom.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1829-2024, Z-1830-2024

Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117

Ongoing Class II Medical devices

Recall started: 19 April 2024
Reason: Event Catalog information does not save when copied and transferred from one unit to another.
Distribution: Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, MA, MI, MN, MO, NJ, NM, NY, OH, PA, TN, TX, WA, WV, & DC. The countries of AE, AT, AU, BE, BR, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IE, IL, IN, IT, JP, KR, LT, NL, NO, OM, PL, PT, RO, SE, SG, SK, TH, & ZA.
Initiated: Voluntary: Firm initiated
Recall number: Z-1827-2024

Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.

Ongoing Class II Medical devices

Recall started: 15 April 2024
Reason: Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1872-2024, Z-1871-2024

Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143

Ongoing Class II Medical devices

Recall started: 29 March 2024
Reason: Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
Distribution: Worldwide distribution - US Nationwide in the states of AZ, HI, MN, VT, WV and the countries of China, Macao, New Zealand, Portugal, Switzerland.
Initiated: Voluntary: Firm initiated
Recall number: Z-1756-2024

The Oncology Essentials Package of the Spectral CT imaging system.

Ongoing Class II Medical devices

Recall started: 22 March 2024
Reason: Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power. may lead to the delay in the detection of a change in a patient condition
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia, Austria, Belgium, Bolivia, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Ecuador, Estonia, Fiji, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Kaza
Initiated: Voluntary: Firm initiated
Recall number: Z-1690-2024

Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider Electric IT Corporati

Ongoing Class II Medical devices

Recall started: 12 March 2024
Reason: Patient support table floor plate may be incorrectly installed.
Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1565-2024, Z-1550-2024, Z-1581-2024, Z-1553-2024, Z-1562-2024, Z-1575-2024, Z-1577-2024, Z-1576-2024, Z-1573-2024, Z-1559-2024, Z-1556-2024, Z-1578-2024 and 29 more

Ingenia 1.5T S, Magnetic Resonance System.
Achieva 1.5T, Magnetic Resonance System.
Intera 1.5T Omni/Stellar, Magnetic Resonance System.
Achieva 3.0T, Magnetic Resonance System.
GYROSCAN T5-NT, Magnetic Resonance System.
Intera 1.5T, Magnetic Resonance System.
Intera 1.5T Achieva Nova, Magnetic Resonance System.
Intera 1.5T Achieva IT Nova, Magnetic Resonance System.
and 33 more product lines

Ongoing Class II Medical devices

Recall started: 28 February 2024
Reason: It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1387-2024, Z-1386-2024

CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X

Ongoing Class II Medical devices

Recall started: 15 February 2024
Reason: If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a patient condition which prompted the alarm to generate. Although unlikely, this could potentially result in a patient harm.
Distribution: Worldwide - US Nationwide distribution in the states of CA, IL, ME, NC, NJ, NM, NY, OH, VA, WA and the countries of Australia, Austria, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, United Kingdom.
Initiated: Voluntary: Firm initiated
Recall number: Z-3312-2024

DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126

Ongoing Class II Medical devices

Recall started: 3 January 2024
Reason: The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0952-2024, Z-0956-2024, Z-0951-2024, Z-0945-2024, Z-0949-2024, Z-0947-2024, Z-0948-2024, Z-0950-2024, Z-0954-2024, Z-0946-2024, Z-0953-2024, Z-0955-2024

Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
Achieva XR. Model (REF) Numbers 781153, 781253.
Achieva 1.5T Initial system. Model (REF) Numbers 781178.
Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
and 4 more product lines

Ongoing Class III Medical devices

Recall started: 29 December 2023
Reason: An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.
Distribution: Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0809-2024, Z-0812-2024, Z-0811-2024, Z-0807-2024, Z-0808-2024, Z-0810-2024

Achieva 3.0T, Model No. 781177
SmartPath to dStream for 1.5T, Model No. 781260, 782112
Intera 1.5T, Model No. 781195
Achieva 1.5T, Model No. 781178, 781196, 781296
Achieva 1.5T Conversion, Model No. 781283
Ingenia Ambition X, Model No. 782109

Ongoing Class I Medical devices

Recall started: 15 December 2023
Reason: Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.
Distribution: Domestic distribution nationwide. International distribution worldwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0929-2024, Z-0931-2024, Z-0930-2024

BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A
BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;

Ongoing Class II Medical devices

Recall started: 15 December 2023
Reason: Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, there is a potential for incorrect patient data to be displayed in the image. Issue 2: Detector Access point: Security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). Due to this vulnerability it is possible, with physical access to the system and knowledge of specific settings, to modify and export data to removable media (example: USB)
Distribution: Nationwide Foreign: Australia Germany India Italy Malaysia Panama Thailand
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1073-2024, Z-1072-2024

ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110

Ongoing Class II Medical devices

Recall started: 7 December 2023
Reason: If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent loss of the ECG signal. Loss of ECG signal may lead to the decision to rescan the patient or delay in diagnosis during a clinical emergency.
Distribution: Domestic distribution to the following states: AL CA CO FL GA HI IL IN KS KY LA MD MI MO MS ND NE NJ NY OH OK PA RI SC TX UT VT WA International distribution worldwide.
Initiated: Voluntary: Firm initiated
Recall number: Z-0719-2024

Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871

Ongoing Class II Medical devices

Recall started: 30 November 2023
Reason: While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0678-2024, Z-0677-2024, Z-0679-2024

BrightView X, Gamma Camera, Product Code 882478
BrightView, Gamma Camera System, Product Code 882480.
BrightView XCT, Gamma Camera, Product Code 882482

Ongoing Class II Medical devices

Recall started: 30 November 2023
Reason: Multiple software issues that affect device functionality.
Distribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Panama, Palestine, Portugal, South Korea, Spain, Switzerland, Thailand, United Kingdom.
Initiated: Voluntary: Firm initiated
Recall number: Z-0725-2024

Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

Ongoing Class II Medical devices

Recall started: 28 November 2023
Reason: Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
Distribution: Worldwide distribution: US (Nationwide) to states of: CA, GA, IA, MA, MI, MN, NJ, NM, NY, OH, PA, TN, TX, WA, WV; and OUS (Foreign) distribution to countries of: Australia, Austria, Belarus, Belgium, Brazil, Canada, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, India,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0731-2024, Z-0732-2024

(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436

Ongoing Class I Medical devices

Recall started: 17 November 2023
Reason: Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain the pressured helium gas due to an unforeseen blockage in the system, risks to patients and/or operators that may lead to injury or death include chemical exposure (i.e. helium gas) that may expand to surrounding rooms, contusion caused by debris, and asphyxia.
Distribution: Domestic distribution to AL AZ CA CO DE FL GA IA IL IN KS KY LA MA MD MI MO NE NJ NV NY OH OK OR PA SC TN TX UT VA VT WA WI WV International distribution to Argentina Austria Canada China Colombia Croatia Czech Republic Denmark Ecuador Egypt France Germany Greece Italy Kuwait Libya Netherlands NO93
Initiated: Voluntary: Firm initiated
Recall number: Z-0505-2024

Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.

Ongoing Class II Medical devices

Recall started: 23 October 2023
Reason: Potential component failure in the Gradient Coil could product smoke and/or fire.
Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, I
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0395-2024, Z-0392-2024, Z-0389-2024, Z-0391-2024, Z-0390-2024, Z-0394-2024, Z-0393-2024

SmartPath to dStream for 1.5T
Ingenia 1.5T CX
Achieva 1.5T
Achieva 1.5T Initial System
Achieva 1.5T Conversion
Intera 1.5T Power/Pulsar
Intera 1.5T

Ongoing Class II Medical devices

Recall started: 9 October 2023
Reason: This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).
Distribution: US Nationwide distribution in the state of MN.
Initiated: Voluntary: Firm initiated
Recall number: Z-0319-2024

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Ongoing Class II Medical devices

Recall started: 9 October 2023
Reason: For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
Distribution: Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0293-2024, Z-0292-2024, Z-0294-2024

Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.

Ongoing Class II Medical devices

Recall started: 9 October 2023
Reason: When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.
Distribution: US Nationwide distribution in the state of MN.
Initiated: Voluntary: Firm initiated
Recall number: Z-0306-2024

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Ongoing Class II Medical devices

Recall started: 4 October 2023
Reason: Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Distribution: United States Territories of Puerto Rico, Guam, and Virgin Islands
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0228-2024, Z-0224-2024, Z-0230-2024, Z-0226-2024, Z-0229-2024, Z-0227-2024

Allura Xper IGTS Fixed Systems
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Veradius Unity Mobile Surgery C-arm
Zenition 50 & 70 Mobile Surgery C-arm
Azurion IGTS Fixed Systems
Integris-Allura IGTS Fixed Systems

Ongoing Class II Medical devices

Recall started: 21 September 2023
Reason: Potential for units suspended on the ceiling to fail and fall.
Distribution: Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0272-2024, Z-0271-2024, Z-0274-2024, Z-0277-2024, Z-0278-2024, Z-0280-2024, Z-0276-2024, Z-0275-2024, Z-0279-2024, Z-0273-2024

DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
and 2 more product lines

Ongoing Class II Medical devices

Recall started: 31 August 2023
Reason: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Distribution: Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2654-2023, Z-2655-2023

EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863359

Ongoing Class II Medical devices

Recall started: 17 August 2023
Reason: Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central patient monitoring. Potential for a delay in the detection of a change or deterioration in the condition of one or more patients
Distribution: Nationwide Foreign: Austria Bahrain Belgium Canada Czech Republic Denmark Finland France Germany Greece India Ireland Italy Japan Jordan Kenya Kuwait Lebanon Lithuania Netherlands Norway Poland Portugal Qatar Romania Slovakia South Africa South Korea Spain Sweden Sweden Switzerland United Kingdom Ut
Initiated: Voluntary: Firm initiated
Recall number: Z-2608-2023

Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC

Ongoing Class II Medical devices

Recall started: 14 June 2023
Reason: Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.
Distribution: Foreign Only: Denmark France Germany Japan United Kingdom
Initiated: Voluntary: Firm initiated
Recall number: Z-0020-2025

IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX50

Ongoing Class II Medical devices

Recall started: 12 June 2023
Reason: During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.
Distribution: US Nationwide. Global Distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2398-2023, Z-2400-2023, Z-2399-2023

Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106

Ongoing Class II Medical devices

Recall started: 12 June 2023
Reason: The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
Distribution: US Nationwide. Global Distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2395-2023, Z-2397-2023, Z-2396-2023

Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106

Ongoing Class II Medical devices

Recall started: 19 May 2023
Reason: There is a software login in issue that may prevent the user from logging in.
Distribution: Distribution in US: AZ, GA, IN, IA, MN, NE, NH, OH, TX OUS distribution to Australia, Chile, China, Malta, Namibia, New Zealand, Oman, Panama, Qatar, Suriname, United Kingdom
Initiated: Voluntary: Firm initiated
Recall number: Z-2042-2023

DigitalDiagnost C90, Model No. 712034 and 712035

Ongoing Class II Medical devices

Recall started: 25 April 2023
Reason: Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
Distribution: Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Mace
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2259-2023, Z-2258-2023, Z-2260-2023, Z-2261-2023

Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
Incisive CT-Computed Tomography X-Ray System Model: 728143
Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
Incisive CT Plus-Computed Tomography X-Ray System Model: 728149

Ongoing Class II Medical devices

Recall started: 19 April 2023
Reason: During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address will be assigned to the MX40. The PIC iX will not recognize the new IP address after reconnecting and therefore the expecting settings sync fails.
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-0035-2025

Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

Ongoing Class II Medical devices

Recall started: 20 March 2023
Reason: Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury
Distribution: Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, MI, MO, NY, TN, TX, VT and the countries of Australia, Chile, Costa Rica, Czech Republic, Dominican, Republic Germany, India, Israel, Japan, Lithuania, Philippines, Poland, Sint Maarten (Dutch part), South Africa, Thailand,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1586-2023, Z-1585-2023

Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814

Ongoing Class II Medical devices

Recall started: 17 March 2023
Reason: Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.
Distribution: Worldwide - US Nationwide distribution including in the states of States: AZ, IN, MA, MD, MN, NY, OH, PA, and TX. The countries of Australia, Austria, China, Czech Republic, Denmark, France, Germany, Israel, Japan, Malaysia, Netherlands, Norway, Palestine, Panama, South Korea, Spain, Switzerland, Th
Initiated: Voluntary: Firm initiated
Recall number: Z-1584-2023

Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333

Ongoing Class II Medical devices

Recall started: 9 March 2023
Reason: If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users
Distribution: Nationwide including Puerto Rico and Virgin Islands Foreign: ARGENTINA Australia Austria Bosnia and Herzegovina Bulgaria China Colombia Cyprus Czech Republic Egypt France French Polynesia Germany Greece Hungary Indonesia Italy Jordan Kenya Latvia Lithuania Macedonia Malta Mexico Netherlands New Zeal
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1382-2023, Z-1383-2023

Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

Ongoing Class II Medical devices

Recall started: 6 March 2023
Reason: EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.
Distribution: Nationwide Foreign: Belgium Brazil Canada Denmark Germany Guam Hong Kong Indonesia Italy Norway Poland Singapore Sweden Switzerland United Kingdom
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1644-2023, Z-1645-2023

EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380

Ongoing Class II Medical devices

Recall started: 3 March 2023
Reason: Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
Distribution: US Nationwide
Initiated: FDA Mandated
Recall numbers: Z-1587-2023, Z-1588-2023, Z-1589-2023

ProxiDiagnost N90 R.1.0
CombiDiagnost R90 R.1.0
CombiDiagnost R90 R1.1

Ongoing Class II Medical devices

Recall started: 18 January 2023
Reason: The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a technical, INOP (inoperable) alarm. The pump may fail prematurely when there is friction caused by an abrasion. This recall is for an IMPORTANT PRODUCT NOTICE dated 1/18/23.
Distribution: US Nationwide. Global Distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-0007-2025

IntelliVue G7m Anesthesia Gas Module, Product Number 866173

Ongoing Class II Medical devices

Recall started: 22 November 2022
Reason: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Distribution: US Nationwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0461-2023, Z-0462-2023, Z-0459-2023, Z-0460-2023, Z-0463-2023

Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Philips MR 7700 System, Model Number 782120
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
Philips Upgrade to MR 7700 System, Model Number 782130

Ongoing Class II Medical devices

Recall started: 21 November 2022
Reason: Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Croatia, Cura¿ao, Czechia, Denmark, Faroe Islands, Finland, France, Germany, Hong Kong, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Luxembourg, Malaysi
Initiated: Voluntary: Firm initiated
Recall number: Z-0908-2023

Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631

Ongoing Class II Medical devices

Recall started: 21 October 2022
Reason: Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and damage the cable. If the tabletop cable breaks, the user may not be able to initiate table tilting movements or braking
Distribution: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Chile, China, Germany, India, Italy, Malaysia, Netherlands, Panama, Spain, Thailand.
Initiated: Voluntary: Firm initiated
Recall number: Z-1477-2023

Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system

Ongoing Class II Medical devices

Recall started: 6 September 2022
Reason: Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.
Distribution: Domestic distribution to AL AZ CA CO FL GA ID IL IN LA MA MI MN NC NE NJ OH PA SC TN TX UT VT WA WY. Foreign distribution to Australia Austria Belgium Czech Republic Denmark Estonia Finland France Germany Ireland Italy Malta Netherlands Norway Poland Portugal Qatar Singapore Slovakia Spain Sweden S
Initiated: Voluntary: Firm initiated
Recall number: Z-0004-2023

MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.

Completed Class II Medical devices

Recall started: 29 March 2022
Reason: Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.
Distribution: Domestic: AL, AR, AZ, CA, FL, GA, HI, IL, IN, KY, LA, MD, ME, MI, MS, NC, NJ, NM, NY, OH, OK, PA, RI, TN, TX; Foreign: Albania, Argentina, Australia, Austria, Bolivia, Bosnia-Herzegovina , Cambodia, Canada, Chile, Colombia, Costa Rica, Czech Republic, Ecuador, Egypt, Ethiopia, France, Germany, Greec
Initiated: Voluntary: Firm initiated
Recall number: Z-0576-2024

The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal

Ongoing Class II Medical devices

Recall started: 25 February 2022
Reason: Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Added 1/3/2023), Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.
Distribution: Nationwide Distribution including Puerto Rico
Initiated: FDA Mandated
Recall number: Z-1563-2022

DigitalDiagnost C50 1.1

Terminated Class II Medical devices

Recall started: 22 February 2022
Terminated: 6 November 2024
Reason: When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure applied will be higher than 150 mmHg and the deflation pressure will be higher than 5 mmHg. An applied cuff inflation pressure higher than 150mmHg or a deflation pressure higher than 5 could lead to bruising, mmHg nerve damage or bone deformity for a neonate.
Distribution: Devices were distributed to the following US states: FL, ID, NJ, OK, SC and TX. Devices were distributed to the following foreign countries: France, Germany, India, Mexico, Netherlands, New Zealand, Norway, Poland, South Africa, and Switzerland.
Initiated: Voluntary: Firm initiated
Recall number: Z-1041-2022

Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic System.

Ongoing Class II Medical devices

Recall started: 7 February 2022
Reason: Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
Distribution: Worldwide distribution: US (nationwide) Including Puerto Rico and OUS (foreign) countries including: Afghanistan, Albania, Algeria, Angola, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Da
Initiated: Voluntary: Firm initiated
Recall number: Z-0926-2022

The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641.

Ongoing Class II Medical devices

Recall started: 4 February 2022
Reason: There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.
Distribution: Worldwide distribution. US Nationwide including Puerto Rico and Guam, Germany, Australia, Sweden, Japan, Canada, Taiwan, France, Netherlands, Spain, Singapore, Austria, South Africa, Italy, United Kingdom, India, Malaysia, Switzerland, Chile, Ireland, Norway, Hong Kong, Argentina, Mexico, Bolivia,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0881-2022, Z-0882-2022

Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS

Ongoing Class II Medical devices

Recall started: 2 February 2022
Reason: Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient.
Distribution: Global Distribution. US Nationwide.
Initiated: Voluntary: Firm initiated
Recall number: Z-0874-2022

Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722

Ongoing Class II Medical devices

Recall started: 6 January 2022
Reason: Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be attracted to MRI systems if the wheels are in the magnetic field.
Distribution: Worldwide - US Nationwide distribution in the states of FL and NY. The countries of Denmark, Norway, and Sweden.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0975-2024, Z-0973-2024, Z-0974-2024

Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system

Terminated Class II Medical devices

Recall started: 3 January 2022
Terminated: 11 April 2024
Reason: eCareManager (eCM) Sentry Score software not approved for use
Distribution: Worldwide distribution - US Nationwide and the country of Australia.
Initiated: Voluntary: Firm initiated
Recall number: Z-0549-2022

eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical

Ongoing Class II Medical devices

Recall started: 29 November 2021
Reason: After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
Distribution: US Nationwide and Canada.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0509-2022, Z-0507-2022, Z-0506-2022, Z-0508-2022

Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Heel Snuggler, Reference # 989805603411 99047
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T

Ongoing Class II Medical devices

Recall started: 26 November 2021
Reason: After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
Distribution: US Nationwide and Canada
Initiated: Voluntary: Firm initiated
Recall number: Z-0505-2022

Infa-Therm Transport Mattress, Reference Number 989805616831 1015

Ongoing Class II Medical devices

Recall started: 24 November 2021
Reason: Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
Distribution: US Nationwide Foreign: Argentina Austria Bangladesh Brazil Chile China Denmark Dominican Republic France Germany Greece India Indonesia Iran Israel Italy Japan Korea, Republic of Malaysia Mexico Netherlands Philippines Russian Federation Saudi Arabia South Africa Spain Sr
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0724-2022, Z-0725-2022

Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 72
Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031

Terminated Class II Medical devices

Recall started: 19 November 2021
Terminated: 7 February 2024
Reason: Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention.
Distribution: Worldwide distribution - US Nationwide distribution in the states of DC, GA, MA, TX, VA and the countries of Dominican Republic, INDIA, Japan, Poland, Spain, Taiwan.
Initiated: Voluntary: Firm initiated
Recall number: Z-0416-2022

Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.

Ongoing Class II Medical devices

Recall started: 12 November 2021
Reason: Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns
Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Algeria, American Samoa, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cameroon, Chile, China, Colombia, Cook Islands, Costa Rica, Croatia, Cuba, Cyprus, Czech Repu
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0355-2022, Z-0357-2022, Z-0356-2022

BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

Terminated Class II Medical devices

Recall started: 12 November 2021
Terminated: 5 February 2024
Reason: (1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available
Distribution: Worldwide distribution - US Nationwide distribution in the state of WA and the countries of France, Germany, Japan, Poland, United Kingdom.
Initiated: Voluntary: Firm initiated
Recall number: Z-0471-2022

Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078,

Ongoing Class II Medical devices

Recall started: 29 October 2021
Reason: Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Australia, Austria, Bangladesh, Belgium, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Ital
Initiated: Voluntary: Firm initiated
Recall number: Z-0476-2022

Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014

Ongoing Class II Medical devices

Recall started: 21 October 2021
Reason: If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.
Distribution: US Nationwide. Global Distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1355-2023, Z-1356-2023

CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110

Terminated Class II Medical devices

Recall started: 24 September 2021
Terminated: 26 September 2024
Reason: When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable.
Distribution: Domestic distribution nationwide. International distribution worldwide.
Initiated: Voluntary: Firm initiated
Recall number: Z-0213-2022

Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3

Terminated Class II Medical devices

Recall started: 13 August 2021
Terminated: 11 March 2024
Reason: Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality will be reduced.
Distribution: US Nationwide distribution in the states of ID, MA, MI, TX, VA.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2474-2021, Z-2476-2021, Z-2475-2021

The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This in
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This i

Completed Class II Medical devices

Recall started: 11 August 2021
Reason: When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republi
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2414-2021, Z-2421-2021, Z-2422-2021, Z-2411-2021, Z-2420-2021, Z-2419-2021, Z-2416-2021, Z-2412-2021, Z-2417-2021, Z-2418-2021, Z-2413-2021, Z-2415-2021

Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the inter
SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any ori
Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the int
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the interna
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the inter
Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the int
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the in
Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of th
and 4 more product lines

Terminated Class II Medical devices

Recall started: 30 July 2021
Terminated: 25 July 2023
Reason: Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Republic of Lebanon, Neth
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2344-2021, Z-2342-2021, Z-2346-2021, Z-2341-2021, Z-2343-2021, Z-2345-2021, Z-2347-2021

Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the int
Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the
Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal
Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the inter
Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the int

Terminated Class II Medical devices

Recall started: 16 July 2021
Terminated: 12 May 2023
Reason: Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient
Distribution: Worldwide distribution. US Nationwide, Australia, Austria, Bolivia, Canada, Chile, China, Denmark, France, French Polynesia, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Republic of Korea, Malta, Martinique, Mexico, Monaco, Netherlands, Norway, Poland, Spain, Switzerland, Taiwan, United Kingdo
Initiated: Voluntary: Firm initiated
Recall number: Z-2427-2021

Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator

Ongoing Class II Medical devices

Recall started: 15 July 2021
Reason: The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)
Distribution: Domestic distribution to the following states and territories: CA DE FL GA IL KY MA ME MI MO NH NJ NM NY OH PA SC TN TX VA VT WI WY, and PR. International distribution worldwide.
Initiated: Voluntary: Firm initiated
Recall number: Z-0715-2024

(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)

Terminated Class II Medical devices

Recall started: 8 June 2021
Terminated: 10 August 2023
Reason: When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
Distribution: US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2318-2021, Z-2317-2021, Z-2316-2021, Z-2314-2021, Z-2315-2021

728333 Spectral CT 7500 -Computed Tomography X-ray system
728332 IQon Spectral CT-Computed Tomography X-ray system
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system

Ongoing Class II Medical devices

Recall started: 1 May 2021
Reason: Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, AE, AR, AT, AU, BD, BE, BR, CH, CL, CN, CO, CU, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GE, GI, GL, GR, HK, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KG, KH, KR, LA, LB, LK, LT, LY, MM, MN, MU, MV, MY, NI, NL, NO, NZ,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1985-2021, Z-1988-2021, Z-1979-2021, Z-1986-2021, Z-1982-2021, Z-1981-2021, Z-1980-2021, Z-1984-2021, Z-1987-2021, Z-1983-2021, Z-1990-2021, Z-1989-2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brilliance 40, Ingenuity Flex 728235 - Brilliance 40 728231/728232 - Bri
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
and 4 more product lines

Ongoing Class II Medical devices

Recall started: 1 May 2021
Reason: Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part
Distribution: US (nationwide) distribution to states of: CA, ME, TX and OUS (Foreign) to countries of: Australia, Germany, Netherlands and Saudi Arabia.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0281-2022, Z-0278-2022, Z-0280-2022, Z-0279-2022, Z-0277-2022

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time C
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce re
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produc
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-

Ongoing Class II Medical devices

Recall started: 23 April 2021
Reason: The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.
Distribution: Domestic: FL, GA, MI, MO, NH, NJ, NY, PA, SC, TX, VT. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Denmark, Finland, France, Germany, Iraq, Italy, Japan, Libya, Moldova, Netherlands, Oman, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1795-2021, Z-1796-2021

Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.

Terminated Class II Medical devices

Recall started: 13 April 2021
Terminated: 23 September 2022
Reason: Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
Distribution: Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.
Initiated: Voluntary: Firm initiated
Recall number: Z-1774-2021

BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306

Ongoing Class II Medical devices

Recall started: 29 March 2021
Reason: Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient weight is rounded to the nearest whole kilogram;Xper IM software used with the Xper Flex Cardio Physio Monitoring System may periodically crash; No SpO2 numeric or plethysmography is displayed when SpO2 is connected o the Flex Cardio device; display of certain data from the FC2010 becomes frozen, i.e., waveforms cease sweeping and updating and the ECG, IBP, and respiration numeric values cease to update;e ECG, IBP, and respiration waveforms become flat lines and no audible alarms are produced for HR and IBP, upon start up, an unexpected non physiological ECG waveform, erratic heart rate numeric value, and non-physiological display of any other active waveforms may appear on the Boom Monitor
Distribution: Nationwide Foreign: Argentina Australia Austria Bangladesh Belgium Bulgaria Canada Chile China Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Estonia Finland France Germany Greece Hungary Iceland India Indonesia Iran Iraq Ireland Israel Italy J
Initiated: Voluntary: Firm initiated
Recall number: Z-1517-2021

Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated

Terminated Class II Medical devices

Recall started: 23 March 2021
Terminated: 28 September 2023
Reason: Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the input signal rate is over 300 bpm, the indicated rate of the affected products will be lower than this upper limit
Distribution: International distribution in the country of China.
Initiated: Voluntary: Firm initiated
Recall number: Z-1326-2021

Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only

Terminated Class II Medical devices

Recall started: 22 February 2021
Terminated: 9 February 2023
Reason: Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees
Distribution: US Virgin Island Foreign: Australia Bolivia China Germany Hungary Indonesia Italy Japan Korea Korea, Republic of Latvia Palestine Philippines Romania Russian Federation Senegal Thailand Uzbekistan
Initiated: Voluntary: Firm initiated
Recall number: Z-1265-2021

Incisive CT Computed Tomography X-ray System Model: 728143

Ongoing Class II Medical devices

Recall started: 9 February 2021
Reason: Customers were not notified of previous recalls associated with various defibrillator models.
Distribution: U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0081-2022, Z-0079-2022, Z-0078-2022, Z-0080-2022

Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A

Terminated Class II Medical devices

Recall started: 2 February 2021
Terminated: 20 September 2022
Reason: Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Distribution: Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.
Initiated: Voluntary: Firm initiated
Recall number: Z-1671-2021

IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parame

Ongoing Class II Medical devices

Recall started: 24 December 2020
Reason: Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured
Distribution: Nationwide including Puerto Rico Foreign: Albania Argentina Australia Austria Bangladesh Bolivia Brazil Bulgaria China Czech Republic Denmark Ecuador Egypt France Germany Greece Hungary India Indonesia Iraq Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kuwait Latvia Lebanon Libya Malaysia M
Initiated: Voluntary: Firm initiated
Recall number: Z-1507-2024

PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143

Terminated Class II Medical devices

Recall started: 19 November 2020
Terminated: 19 April 2023
Reason: A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, Algeria, Argentina, Australia, Bahrain, Austria, Belgium, Brazil, China, Columbia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, India, Indonesia, Iran, Ireland, Isra
Initiated: Voluntary: Firm initiated
Recall number: Z-0852-2021

Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

Terminated Class II Medical devices

Recall started: 18 November 2020
Terminated: 22 July 2021
Reason: Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.
Distribution: Worldwide distribution - US Nationwide distribution in the state of SD and the countries of China, England, Germany, Hong Kong, Portugal.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0545-2021, Z-0544-2021

Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital
Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates

Terminated Class II Medical devices

Recall started: 14 September 2020
Terminated: 13 September 2022
Reason: The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that includes a test for the switched paddles only, which will detect this failure mode.
Distribution: Global Distribution. US Nationwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0284-2021, Z-0285-2021

Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator
Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillato

Terminated Class II Medical devices

Recall started: 16 July 2020
Terminated: 3 August 2021
Reason: The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user. These device behaviors could result in a delay in therapy or a failure to deliver the intended therapy.
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-2794-2020

Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital

Terminated Class II Medical devices

Recall started: 30 June 2020
Terminated: 25 January 2024
Reason: Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not followed, and may also cause the monitor to stop operating or prevent it from being switched on.
Distribution: Domestic distribution to CA, HI, MA, NY, and UT. International distribution to Costa Rica, Ireland, Lebanon, and Poland.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2696-2020, Z-2697-2020

IntelliVue MX800 patient monitor, model no. 865240
IntelliVue MX700 patient monitor, model no. 865241

Ongoing Class II Medical devices

Recall started: 25 June 2020
Reason: The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and generating one or more technical or INOP alarms.
Distribution: Worldwide distribution - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-2689-2020

IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173

Terminated Class II Medical devices

Recall started: 18 June 2020
Terminated: 10 January 2023
Reason: A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger.
Distribution: World wide distribution. Firm reports distributing more product then quantity manufactured. Clarification requested. And received. Firm made error in counting number of batteries distributed.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2812-2020, Z-2810-2020, Z-2811-2020

Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing
Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for pati
Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients underg

Terminated Class II Medical devices

Recall started: 8 June 2020
Terminated: 9 January 2023
Reason: Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and lntelliVue MMX multi-measurement server (Model No. 867036).If they are connected to a host monitor, communication with the X3 or MMX could be disrupted, resulting in a loss of monitoring on the host monitor.
Distribution: Nationwide Foreign: Angola Angola Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Guiana Germany Ghana Gibraltar Greece Greenlan
Initiated: Voluntary: Firm initiated
Recall number: Z-2531-2020

Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)

Terminated Class II Medical devices

Recall started: 2 June 2020
Terminated: 9 February 2021
Reason: Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CT, FL, GA, HI, IL, LA, MA, MD, MI, MS, MT, NC, NY, TN, TX and the country of Panama.
Initiated: Voluntary: Firm initiated
Recall number: Z-2523-2020

EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.

Terminated Class II Medical devices

Recall started: 19 May 2020
Terminated: 25 August 2020
Reason: Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that was not intended for commercial distribution and for which Philips does not have records regarding its manufacture. Philips is therefore removing this device from distribution.
Distribution: US Nationwide distribution including in the state of NJ.
Initiated: Voluntary: Firm initiated
Recall number: Z-2337-2020

Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intui

Terminated Class II Medical devices

Recall started: 27 April 2020
Terminated: 19 July 2021
Reason: HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
Distribution: Worldwide distribution - US Nationwide distribution and the countries of China, Republic of Korea, Netherlands, Norway, United Kingdom.
Initiated: Voluntary: Firm initiated
Recall number: Z-2157-2020

Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.

Terminated Class II Medical devices

Recall started: 23 April 2020
Terminated: 30 March 2023
Reason: The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution Unit, may be incorrectly installed and not working. If the transformer overheats due to a first failure and the thermo switch is not activated, the device may begin to generate smoke.
Distribution: Domestic distribution nationwide. Foreign distribution to Chile and Germany.
Initiated: Voluntary: Firm initiated
Recall number: Z-2256-2020

ProxiDiagnost N90, UDI 706100

Terminated Class II Medical devices

Recall started: 21 April 2020
Terminated: 16 July 2021
Reason: HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
Distribution: Worldwide distribution - US Nationwide distribution including in the states of KY, MA, ND, NY and the countries of United Kingdom, Bahrain.
Initiated: Voluntary: Firm initiated
Recall number: Z-2137-2020

Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life

Terminated Class II Medical devices

Recall started: 20 April 2020
Terminated: 2 April 2021
Reason: Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine operational checks are followed. The instructions for use rely on these checks rather than specifying a maximum number of sterilization cycles to determine when the paddles should be discarded. A damaged Internal Paddle may not be able to deliver therapy.
Distribution: Worldwide distribution - US Nationwide distrubtion and the countries of Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Congo (Democratic Republic of the), Costa Rica, C¿te D'Ivoire, Cyprus, Czec
Initiated: Voluntary: Firm initiated
Recall number: Z-2134-2020

Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - P

Terminated Class II Medical devices

Recall started: 13 April 2020
Terminated: 7 April 2021
Reason: The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.
Distribution: Worldwide distribution - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-2053-2020

Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life

Terminated Class II Medical devices

Recall started: 13 April 2020
Terminated: 14 April 2023
Reason: The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2245-2020, Z-2244-2020

Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration b
Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting

Terminated Class II Medical devices

Recall started: 10 April 2020
Terminated: 11 January 2021
Reason: When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V) and/or the video signal can be lost.
Distribution: Worldwide distribution - US Nationwide distribution including in the states of MD and MI. The countries of Austria, Belgium, France, Germany, Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1933-2020, Z-1932-2020

Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth
Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth

Terminated Class II Medical devices

Recall started: 10 April 2020
Terminated: 10 February 2021
Reason: Damaged ESD bags used for storing components in Processor PCA Replacement Kits
Distribution: Worldwide distribution - US Nationwide distribution including in the states of OK, NY and the countries of Libya, Netherlands, Canada, South Africa, United Kingdom.
Initiated: Voluntary: Firm initiated
Recall number: Z-2064-2020

HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified m

Terminated Class II Medical devices

Recall started: 7 April 2020
Terminated: 28 April 2023
Reason: If the shaft breaks due to material fatigue, the trauma arm can fall down and may result in injury.
Distribution: Worldwide distribution - US Nationwide distribution including the states of CA, ME, RI, TX, WI and the countries of Canada, Australia, Austria, France, Germany, Greece, Hungary, Ireland, Netherlands, Portugal, Slovenia, United Kingdom.
Initiated: Voluntary: Firm initiated
Recall number: Z-1806-2020

Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.

Terminated Class II Medical devices

Recall started: 6 April 2020
Terminated: 16 September 2022
Reason: The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.
Distribution: Worldwide distribution including one unit distributed to Iowa.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1922-2020, Z-1921-2020, Z-1923-2020

Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067

Terminated Class II Medical devices

Recall started: 3 April 2020
Terminated: 1 February 2023
Reason: When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning message directs the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use of live guidance if the L-arm stand is not repositioned. Using live guidance with a mispositioned L-arm can result in the display of an incorrect overlay and needle path.
Distribution: Worldwide distribution. US states of FL, ID, IL, IN, MA, and OH, Canada, Australia, Austria, Belgium, Germany, and Netherlands New Zealand, South Africa, Switzerland, Thailand
Initiated: Voluntary: Firm initiated
Recall number: Z-1809-2020

Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079

Terminated Class II Medical devices

Recall started: 5 March 2020
Terminated: 9 September 2022
Reason: No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becoming loose..
Distribution: Worldwide distribution: US (nationwide) including the following states: Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio,
Initiated: Voluntary: Firm initiated
Recall number: Z-1801-2020

Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular

Terminated Class II Medical devices

Recall started: 5 March 2020
Terminated: 11 February 2021
Reason: The ECG signal from patients being monitored using a Philips TRx4841A and TRx4851A Telemetry Transceiver may not be properly analyzed when it is used with a Philips Patient Information Center iX Release C.02.xx or C.03.01. If this occurs, the Information Center will not display a heart rate or generate, display or annunciate any heart rate or arrhythmia alarms.
Distribution: The products were distributed US nationwide. Global distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1767-2020, Z-1766-2020

TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861

Terminated Class II Medical devices

Recall started: 26 February 2020
Terminated: 8 December 2022
Reason: Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a severe mechanical shock, even though the device did not have visible external damage or the Ready for Use ( RFU ) indicator on the unit did not immediately indicate a problem. One of these reports involved a death of a patient who could not be resuscitated.
Distribution: US Nationwide domestic distribution. Worldwide foreign distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1499-2020

HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.

Terminated Class II Medical devices

Recall started: 20 February 2020
Terminated: 21 September 2021
Reason: Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing the O2 sensor calibration are incorrect for customers performing this task with an MR400 device with software revisions: 01 .03.00, 01.04.00, 01 .05.00 and 01 .07.00
Distribution: Worldwide distribution - US Nationwide distribution and countries of Utd Arab Emir, Albania, Austria, Australia, Azerbaijan, Bulgaria, Brazil, White Russia, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary,
Initiated: Voluntary: Firm initiated
Recall number: Z-1616-2020

Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitoring Systems is int

Terminated Class II Medical devices

Recall started: 14 January 2020
Terminated: 9 February 2021
Reason: M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
Distribution: International distribution in the countries of Austria, Germany, Netherlands, Norway, Poland, Switzerland
Initiated: Voluntary: Firm initiated
Recall number: Z-1342-2020

Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments.

Terminated Class II Medical devices

Recall started: 13 January 2020
Terminated: 22 June 2023
Reason: if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display Error: 602 and fail to function for a new patient study.
Distribution: US Nationwide Foreign: Afghanistan Albania Algeria Argentina Armenia Aruba Australia Austria Azerbaijan Bangladesh Belarus Belgium Bermuda Bulgaria Burkina Faso Canada China C¿te D'Ivoire Croatia Curacao Cyprus Czech Republic Egypt France Germany Ghana Gibraltar Greece
Initiated: Voluntary: Firm initiated
Recall number: Z-1345-2020

Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: - 453564067

Terminated Class II Medical devices

Recall started: 30 December 2019
Terminated: 17 November 2022
Reason: A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
Distribution: Nationwide domestic distribution. Foreign distribution worldwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1488-2020, Z-1494-2020, Z-1492-2020, Z-1490-2020, Z-1487-2020, Z-1489-2020, Z-1491-2020, Z-1493-2020, Z-1486-2020

Integris Allura 9, system codes 722018 722021
Cardio Vascular-Allura Centron, system code 722400
UroDiagnost Eleva, system code 708033
OmniDiagnost Eleva System codes 708028 708027
Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
Poly G Integris H5000, System code 72246
Allura CV20, system code 722031
and 1 more product lines

Terminated Class II Medical devices

Recall started: 23 December 2019
Terminated: 17 November 2022
Reason: Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.
Distribution: Worldwide Distribution. US nationwide, Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Latvia, Libya, Mexico, Netherland
Initiated: Voluntary: Firm initiated
Recall number: Z-1145-2020

VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azu

Terminated Class II Medical devices

Recall started: 20 November 2019
Terminated: 4 April 2024
Reason: Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
Distribution: United States
Initiated: FDA Mandated
Recall number: Z-3023-2020

ProxiDiagnost N90

Terminated Class II Medical devices

Recall started: 16 October 2019
Terminated: 29 November 2023
Reason: The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user.
Distribution: US Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-0498-2020

HeartStart XL+ Defibrillator/Monitor, Model 861290

Terminated Class II Medical devices

Recall started: 3 October 2019
Terminated: 19 April 2023
Reason: Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device will indicate that it is not ready for use.
Distribution: US Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-0608-2020

HeartStart XL+ Defibrillator/Monitor, Model 861290

Terminated Class II Medical devices

Recall started: 10 September 2019
Terminated: 29 April 2024
Reason: Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
Distribution: HeartStart FRx: US - CA, CT, FL, IL, MO, NY,TN, TX and WI OUS - Australia, Brazil, Canada, Germany, Italy, Japan, South Korea, Norway, Switzerland and Taiwan. HeartStart HS1: US - CT, FL, IL, MI, MS, NJ, TN, TX, WA and WI OUS - Argentina, Australia, Canada, France, Germany, Hong Kong, Italy,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1272-2020, Z-1271-2020

Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017

Terminated Class II Medical devices

Recall started: 23 August 2019
Terminated: 3 January 2024
Reason: Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations
Distribution: Nationwide
Initiated: Voluntary: Firm initiated
Recall number: Z-2547-2019

IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (P

Terminated Class II Medical devices

Recall started: 19 July 2019
Terminated: 3 June 2020
Reason: The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements.
Distribution: Worldwide Distribution - US Nationwide State KY AZ CA UT OH NY SC CO FL IN TX ND KS GA Canada Germany
Initiated: Voluntary: Firm initiated
Recall number: Z-2495-2019

Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration

Terminated Class II Medical devices

Recall started: 16 July 2019
Terminated: 4 June 2020
Reason: The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.
Distribution: US Nationwide Distribution Foreign: Canada Argentina AUSTRALIA Austria Azerbaijan Bahrain Bangladesh Belgium Bosnia and Herzegovina Brazil Bulgaria Chile Colombia CROATIA Denmark ECUADOR Egypt Finland France Germany Greece Hong Kong India Indonesia Ireland Israel Italie
Initiated: Voluntary: Firm initiated
Recall number: Z-2205-2019

Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 72206

Terminated Class II Medical devices

Recall started: 16 July 2019
Terminated: 20 October 2022
Reason: Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices.
Distribution: US Nationwide distribution in the state of MA.
Initiated: Voluntary: Firm initiated
Recall number: Z-2488-2019

HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automat

Terminated Class II Medical devices

Recall started: 7 June 2019
Terminated: 8 May 2020
Reason: The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery.
Distribution: Nationwide domestic distribution. Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1923-2019

Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9

Terminated Class III Medical devices

Recall started: 29 April 2019
Terminated: 22 November 2024
Reason: Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX using a LAN driver may be recorded in the patients chart or electronic medical record at exactly 100 times the actual bolus rate, infusion rate and total volume values
Distribution: Worldwide Distribution - US Nationwide Foreign: Andorra Aruba Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Costa Rica Croatia Czech Republic Denmark Dominican Rep Egypt Estonia Finland France French Gui
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1772-2019, Z-1771-2019

Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator: 866417 IntelliBridge System C.01 (or later) 866418 IntelliBridge System C.01 upgrade (or later) Product U
Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgra

Ongoing Class II Medical devices

Recall started: 19 April 2019
Reason: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Distribution: Worldwide distribution. US Nationwide including Puerto Rico, Andorra, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Dominican Republic, Egypt, France, French Guiana, French Polynesia, Germany, Gibraltar
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1318-2019, Z-1321-2019, Z-1322-2019, Z-1319-2019, Z-1324-2019, Z-1320-2019, Z-1317-2019, Z-1323-2019

SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

Ongoing Class II Medical devices

Recall started: 28 March 2019
Reason: The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
Distribution: Worldwide distribution - US Nationwide and to 71 countries.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1693-2019, Z-1692-2019, Z-1694-2019, Z-1695-2019

IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467821, 453564467841,
IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Ce
IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 Product Usage: Used primarily as a traditional telemetr
IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Informa

Terminated Class II Medical devices

Recall started: 12 March 2019
Terminated: 7 October 2020
Reason: During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.
Distribution: Distributed to one account in Florida, and one international account in Germany.
Initiated: Voluntary: Firm initiated
Recall number: Z-1130-2019

Azurion FlexArm, 722079

Terminated Class II Medical devices

Recall started: 28 February 2019
Terminated: 3 August 2020
Reason: The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
Distribution: US Nationwide domestic distribution, and worldwide international distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1052-2019, Z-1054-2019, Z-1055-2019, Z-1056-2019, Z-1053-2019

MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more spe
Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of r
MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be perfo
URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine exa
Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde py

Terminated Class II Medical devices

Recall started: 25 January 2019
Terminated: 8 December 2020
Reason: During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.
Distribution: Distributed nationwide within US. Worldwide international distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1250-2019

Fetal Spiral Electrode, Model No. 9898 031 37631

Terminated Class II Medical devices

Recall started: 25 January 2019
Terminated: 21 April 2020
Reason: Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor
Distribution: US Nationwide distribution in the states of AK, CA, CO, IN,MI, NC, ND, NM, OR, TN, TX and UT.
Initiated: Voluntary: Firm initiated
Recall number: Z-1067-2019

Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological paramet

Ongoing Class II Medical devices

Recall started: 9 January 2019
Reason: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0853-2019, Z-0854-2019, Z-0856-2019, Z-0855-2019, Z-0861-2019, Z-0859-2019, Z-0857-2019, Z-0858-2019, Z-0860-2019

PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evaluate the electrocardiogram of adult and pediatric patients
PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
and 1 more product lines

Terminated Class II Medical devices

Recall started: 23 November 2018
Terminated: 29 September 2020
Reason: Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the Monitor/Defibrillator, which may prevent operation of the device if it is not connected to AC or DC power. Should a second, unaffected battery be present in the Monitor/Defibrillator, the battery failure may go unnoticed.
Distribution: U.S.: AZ, WA, PA, UT, NY, CO, MD, AR, TX, MO, MI, FL, VA, MA, GA, TN, NV, OH, CA, NH, KY, KS, OR, WI, NC, IL, LA, NJ, WV, AL, WY, MS Foreign (OUS): United Kingdom, Korea Rep, Singapore, Australia, Taiwan, Sri Lanka, Brazil, France, Switzerland, Germany, Austria, Spain, Italy, Trinidad and Tobago,
Initiated: Voluntary: Firm initiated
Recall number: Z-0603-2019

HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.

Terminated Class II Medical devices

Recall started: 8 August 2018
Terminated: 29 April 2021
Reason: The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child pad cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the Adult pads cartridge and may therefore not be effective on an adult.
Distribution: US: AK, AL,AR,AZ,CA,CO,CT,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV, WY, Argentina, Aruba, Australia, Austria, Belgium, Bolivia, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Denmar
Initiated: Voluntary: Firm initiated
Recall number: Z-2549-2019

Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758

Terminated Class I Medical devices

Recall started: 12 July 2017
Terminated: 27 May 2020
Reason: Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.
Distribution: No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom
Initiated: Voluntary: Firm initiated
Recall number: Z-0489-2018

MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.