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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls

59 recalls recorded since 2018, most recently on 16 July 2026. 59 are listed as ongoing. Status and classification are as published by the FDA.

Recalls59

Ongoing (FDA)59

Terminated or completed0

Class I (FDA)1

Ongoing Class II Medical devices

Recall started: 16 July 2026
Reason: Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
Distribution: Worldwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-2932-2026

Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system

Ongoing Class II Medical devices

Recall started: 16 July 2026
Reason: Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
Distribution: Worldwide
Initiated: Voluntary: Firm initiated
Recall number: Z-2931-2026

Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only i

Ongoing Class II Medical devices

Recall started: 29 June 2026
Reason: Firmware issue potentially leading to loss of geometry movements.
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece,
Initiated: Voluntary: Firm initiated
Recall number: Z-2928-2026

Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.

Ongoing Class II Medical devices

Recall started: 17 June 2026
Reason: Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2893-2026, Z-2892-2026, Z-2891-2026

Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; M
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper

Ongoing Class II Medical devices

Recall started: 18 May 2026
Reason: Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
Distribution: US and ROW.
Initiated: FDA Mandated
Recall numbers: Z-2411-2026, Z-2412-2026

Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 70803
Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 72200

Ongoing Class II Medical devices

Recall started: 30 April 2026
Reason: It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussal, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czec
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2258-2026, Z-2259-2026

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (7220
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 72201

Ongoing Class II Medical devices

Recall started: 28 April 2026
Reason: The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
Distribution: Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, E
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2227-2026, Z-2229-2026, Z-2228-2026

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (7

Ongoing Class II Medical devices

Recall started: 28 April 2026
Reason: Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
Distribution: Nationwide distribution. International distribution to Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, C¿te D'Ivoire, El Salvador, Estonia, Greece, Honduras, Hong Kong, Iceland, Indonesia, Ira
Initiated: Voluntary: Firm initiated
Recall number: Z-2225-2026

Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3

Ongoing Class II Medical devices

Recall started: 31 March 2026
Reason: Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Initiated: Voluntary: Firm initiated
Recall number: Z-2170-2026

Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion

Ongoing Class II Medical devices

Recall started: 19 March 2026
Reason: Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bnis insted Us Instas instes, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Estonia, Germany, Greece, Indonesia, Iraq, Italy, Japan, Kuwait, Latvia, Ma
Initiated: Voluntary: Firm initiated
Recall number: Z-1805-2026

Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

Ongoing Class II Medical devices

Recall started: 5 March 2026
Reason: Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Andorra, Angola, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany,
Initiated: Voluntary: Firm initiated
Recall number: Z-1692-2026

Vue Motion V12. Product Number: 1017979.

Ongoing Class II Medical devices

Recall started: 3 March 2026
Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colo
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1664-2026, Z-1672-2026, Z-1673-2026, Z-1676-2026, Z-1679-2026, Z-1666-2026, Z-1660-2026, Z-1668-2026, Z-1665-2026, Z-1674-2026, Z-1677-2026, Z-1680-2026 and 10 more

ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
Allura Xper FD20/15 OR Table; System Code: 722059;
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Azurion 5 M12; System Code: (1)722227, (2)722231;
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
ALLURA Xper FD10F; System Code: 722002;
Allura Xper FD20/10; System Code: 722029;
and 14 more product lines

Ongoing Class II Medical devices

Recall started: 26 January 2026
Reason: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1348-2026, Z-1349-2026, Z-1346-2026, Z-1350-2026, Z-1345-2026, Z-1344-2026, Z-1347-2026, Z-1351-2026

Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Ongoing Class II Medical devices

Recall started: 15 December 2025
Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Ken
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1063-2026, Z-1074-2026, Z-1075-2026, Z-1062-2026, Z-1064-2026, Z-1069-2026, Z-1077-2026, Z-1065-2026, Z-1070-2026, Z-1076-2026, Z-1068-2026, Z-1067-2026 and 4 more

Allura Xper FD10F; Model Number: 722002;
Allura Xper FD10/10; Model Number: 722027;
Allura Xper FD20; Model Number: 722028;
Product Name: Allura Xper FD10C; Model number: 722001;
Allura Xper FD10; Model Number: 722003;
Allura Xper FD10/10; Model Number: 722011;
Allura Xper FD20/20; Model Number: 722038;
Allura Xper FD10/10; Model Number: 722005;
and 8 more product lines

Ongoing Class II Medical devices

Recall started: 12 December 2025
Reason: Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.
Distribution: International distribution in the countries of AE, AR, AT, AZ, BE, BG, BH, BR, BS, CH, CL, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, GB, GR, GT, ID, IE, IL, IN, IQ, IT, JE, JP, LB, MA, MO, NI, NL, NO, PE, PL, RO, SA, SE, SV, TR, UA, VE, VN, ZA;
Initiated: Voluntary: Firm initiated
Recall number: Z-1113-2026

Philips Azurion system; Software Version Number: R3.1;

Ongoing Class II Medical devices

Recall started: 12 December 2025
Reason: Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.
Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chil
Initiated: Voluntary: Firm initiated
Recall number: Z-1091-2026

Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numb

Ongoing Class II Medical devices

Recall started: 8 December 2025
Reason: Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Chile, Colombia, Cote de'Ivore, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia
Initiated: Voluntary: Firm initiated
Recall number: Z-1079-2026

Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number:

Ongoing Class II Medical devices

Recall started: 2 October 2025
Reason: The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.
Distribution: Domestic: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MD, MN, MO, NM, NY, OH, OK, PA, RI, TX, UT, VA, WA, WI, WV, WY; International: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Iraq, Italy, Japan, Netherlands, Norway, Philippines,
Initiated: Voluntary: Firm initiated
Recall number: Z-0719-2026

Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;

Ongoing Class II Medical devices

Recall started: 29 September 2025
Reason: Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
Distribution: Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.
Initiated: Voluntary: Firm initiated
Recall number: Z-0241-2026

Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system

Ongoing Class II Medical devices

Recall started: 3 September 2025
Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Fiji, Fi
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2627-2025, Z-2633-2025, Z-2624-2025, Z-2634-2025, Z-2625-2025, Z-2635-2025, Z-2623-2025, Z-2628-2025, Z-2631-2025, Z-2629-2025, Z-2626-2025, Z-2630-2025 and 1 more

Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
and 5 more product lines

Ongoing Class II Medical devices

Recall started: 3 September 2025
Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmar
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0002-2026, Z-0010-2026, Z-0009-2026, Z-0013-2026, Z-0004-2026, Z-0001-2026, Z-0007-2026, Z-0014-2026, Z-0006-2026, Z-0012-2026, Z-0015-2026, Z-0011-2026 and 3 more

Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
and 7 more product lines

Ongoing Class II Medical devices

Recall started: 8 August 2025
Reason: Software issue that results in the display of outdated information.
Distribution: US Nationwide distribution in the states of GA, NC & TX.
Initiated: Voluntary: Firm initiated
Recall number: Z-2543-2025

IntelliSpace Cardiovascular, Software 8.0.0.4.

Ongoing Class II Medical devices

Recall started: 1 August 2025
Reason: Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hun
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2502-2025, Z-2503-2025

Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Mode

Ongoing Class II Medical devices

Recall started: 1 August 2025
Reason: Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
Distribution: Worldwide - US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, HI, ID, IL, KS, KY, LA, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI, WV and the countries of Argentina, Austria, Australia, Belgium, Switzerland, Chile, China, Colombia, Czechia, Germany, Egypt, Spain,
Initiated: Voluntary: Firm initiated
Recall number: Z-2504-2025

Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 7220

Ongoing Class II Medical devices

Recall started: 30 June 2025
Reason: Potential for temporary loss of imaging (X-ray) functionality due to software issue.
Distribution: Worldwide - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polyn
Initiated: Voluntary: Firm initiated
Recall number: Z-2189-2025

Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20

Ongoing Class II Medical devices

Recall started: 4 June 2025
Reason: Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Distribution: Worldwide distribution: US (nationwide) to states of: CA, CO, DC, DE, FL, IL, IN, KY, MA, MD, MN, MO, MT, NJ, NV, NY, OH, SC, TX, WA; and OUS (Foreign) to countries of: Argentina (AR), Australia (AU), Canada (CA), Chile (CL), Germany (DE), Dominican Republic (DO), Egypt (EG), ES, France (FR), United
Initiated: Voluntary: Firm initiated
Recall number: Z-2134-2025

Azurion 7 M20. Fluoroscopic X-Ray System.

Ongoing Class II Medical devices

Recall started: 28 May 2025
Reason: A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).
Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica
Initiated: Voluntary: Firm initiated
Recall number: Z-1969-2025

Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228,

Ongoing Class II Medical devices

Recall started: 7 April 2025
Reason: An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
Distribution: Domestic: Nationwide Distribution International: Australia, Austria, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Luxembourg, Mexico, Netherlands, Norway, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, U
Initiated: Voluntary: Firm initiated
Recall number: Z-1740-2025

IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

Ongoing Class II Medical devices

Recall started: 24 March 2025
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: US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican R
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1776-2025, Z-1783-2025, Z-1775-2025, Z-1782-2025, Z-1772-2025, Z-1770-2025, Z-1777-2025, Z-1771-2025, Z-1780-2025, Z-1778-2025, Z-1779-2025, Z-1774-2025 and 2 more

Intera 1.5T Master/Nova, Model Number: 781106;
SmartPath to dStream for 3.0T, Model Number: 782145;
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
SmartPath to dStream for 1.5T, Model Number: 782146;
Intera 1.0T Omni/Stellar, Model Number: 781102;
Enterprise 1.5T, Model Number: 781145;
Intera 1.5T Omni/Stellar, Model Number: 781104;
Intera 0.5T Standard, Model Number: 781101;
and 6 more product lines

Ongoing Class II Medical devices

Recall started: 28 February 2025
Reason: Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
Distribution: Domestic: MN
Initiated: Voluntary: Firm initiated
Recall number: Z-1324-2025

Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;

Ongoing Class II Medical devices

Recall started: 13 January 2025
Reason: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, Chin
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1087-2025, Z-1091-2025, Z-1076-2025, Z-1092-2025, Z-1080-2025, Z-1084-2025, Z-1081-2025, Z-1094-2025, Z-1083-2025, Z-1086-2025, Z-1089-2025, Z-1078-2025 and 7 more

Azurion 3 M12 System Code: (1) 722063 (2) 722221
Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
Allura CV20 System Code: 722031
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
AlluraXperFD20/10 System Code: (1) 722029
AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
and 11 more product lines

Ongoing Class I Medical devices

Recall started: 13 January 2025
Reason: Possibility of the patient falling from the table related to the mattress used on the patient table.
Distribution: Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1145-2025, Z-1154-2025, Z-1151-2025, Z-1160-2025, Z-1153-2025, Z-1144-2025, Z-1146-2025, Z-1149-2025, Z-1155-2025, Z-1147-2025, Z-1158-2025, Z-1157-2025 and 8 more

Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
Allura CV20; Catalog numbers: 722031
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
Allura Xper FD20/15; Catalog numbers: 722058
and 12 more product lines

Ongoing Class II Medical devices

Recall started: 11 November 2024
Reason: Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.
Distribution: Nationwide distribution. International distribution to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, Franc
Initiated: Voluntary: Firm initiated
Recall number: Z-0676-2025

Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allur

Ongoing Class II Medical devices

Recall started: 7 October 2024
Reason: Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Isla
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0352-2025, Z-0353-2025

Philips Zenition 50, Model Number: 718096
Philips Zenition 70, Model Number: 718133

Ongoing Class II Medical devices

Recall started: 22 August 2024
Reason: Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Distribution: Nationwide, Canada and Worldwide: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Brazil Brunei Darussalam Bulgaria Cambodia Cayman Islands Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cuba Curacao Cyprus Czech
Initiated: Voluntary: Firm initiated
Recall numbers: Z-3165-2024, Z-3167-2024, Z-3166-2024, Z-3168-2024

System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion 7 B20 722225 Azurio
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C /
System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 Allura Xper FD20 OR Table 722029 Allura Xper FD20/10 722028 Allura Xper FD
System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost Eleva

Ongoing Class II Medical devices

Recall started: 8 August 2024
Reason: A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
Distribution: Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.
Initiated: Voluntary: Firm initiated
Recall number: Z-2716-2024

Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013

Ongoing Class II Medical devices

Recall started: 6 August 2024
Reason: The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel.
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-2953-2024

Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224

Ongoing Class II Medical devices

Recall started: 15 July 2024
Reason: Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cyprus, Cze
Initiated: Voluntary: Firm initiated
Recall number: Z-2534-2024

Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the follo

Ongoing Class II Medical devices

Recall started: 16 May 2024
Reason: When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
Distribution: Domestic: OK International: India, Spain, U.A.E.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1896-2024, Z-1897-2024, Z-1895-2024

Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.

Ongoing Class II Medical devices

Recall started: 2 May 2024
Reason: Potential for pressure wave data synchronization from two devices may not be correct.
Distribution: Worldwide distribution - US Nationwide in the states of CA, IN, OR and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, Costa Rica, C¿te D'Ivoire, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hungary, India, Ireland, Italy, Malaysia, Martinique, N
Initiated: Voluntary: Firm initiated
Recall number: Z-1926-2024

Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

Ongoing Class II Medical devices

Recall started: 4 April 2024
Reason: Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Distribution: US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA, IN, KY, MA, MI, MN, NC, NE, NY, OH, OR, TN, TX, VA, and WI. There was government distribution but no military distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-1252-2025

Philips IntelliSpace Cardiovascular software, Model 830089.

Ongoing Class II Medical devices

Recall started: 6 February 2024
Reason: Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
Distribution: Worldwide distribution - US Nationwide distribution in the states of NY, PA, PR, TN, TX, VA, WA and the countries of Algeria, Armenia, Austria, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Korea, Repub
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1178-2024, Z-1176-2024, Z-1177-2024

Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228

Ongoing Class II Medical devices

Recall started: 2 January 2024
Reason: Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1145-2024, Z-1144-2024

Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD

Ongoing Class II Medical devices

Recall started: 2 January 2024
Reason: Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
Distribution: Worldwide Distribution: US nationwide including states of: AL, AK, 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, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and OUS (International) to countries of: Af
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1152-2024, Z-1151-2024

Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name -

Ongoing Class II Medical devices

Recall started: 2 January 2024
Reason: Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
Distribution: Worldwide Distribution: US nationwide including states of: AL, AK, 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, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and OUS (International) to countries of: Af
Initiated: Voluntary: Firm initiated
Recall number: Z-1156-2024

Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 72201

Ongoing Class II Medical devices

Recall started: 12 December 2023
Reason: System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall number: Z-0835-2024

Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion

Ongoing Class II Medical devices

Recall started: 8 December 2023
Reason: Loss of connectivity between the FlexArm and the Table due to a software issue.
Distribution: Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.
Initiated: Voluntary: Firm initiated
Recall number: Z-0860-2024

Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

Ongoing Class II Medical devices

Recall started: 8 December 2023
Reason: Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.
Distribution: Worldwide - US Nationwide distribution in the states of CO, FL, IL, MS, NV and TX. The country of Canada.
Initiated: Voluntary: Firm initiated
Recall number: Z-0861-2024

Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

Ongoing Class II Medical devices

Recall started: 7 December 2023
Reason: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Distribution: US Nationwide distribution.
Recall numbers: Z-2285-2026, Z-2284-2026, Z-2288-2026, Z-2290-2026, Z-2287-2026, Z-2291-2026, Z-2289-2026, Z-2286-2026

Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

Ongoing Class II Medical devices

Recall started: 3 November 2023
Reason: Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose
Distribution: Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, CANADA, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Rep
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0559-2024, Z-0558-2024

Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table

Ongoing Class II Medical devices

Recall started: 15 August 2023
Reason: A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
Distribution: Worldwide distribution
Initiated: Voluntary: Firm initiated
Recall number: Z-2587-2023

Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems

Ongoing Class II Medical devices

Recall started: 20 July 2023
Reason: Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Distribution: US Nationwide distribution
Initiated: FDA Mandated
Recall number: Z-1583-2025

Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.

Ongoing Class II Medical devices

Recall started: 19 July 2023
Reason: A 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 Nationwide Distribution
Initiated: FDA Mandated
Recall numbers: Z-2402-2023, Z-2403-2023, Z-2404-2023

Allura Xper series
Azurion
MultiDiagnost-Eleva

Ongoing Class II Medical devices

Recall started: 30 June 2023
Reason: Loss of availability of the wireless foot switch during procedures.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Chile, China, Croatia, Czech Republic, Denmark, Egypt, Fiji, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kor
Initiated: Voluntary: Firm initiated
Recall number: Z-2485-2023

Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems

Ongoing Class II Medical devices

Recall started: 12 June 2023
Reason: The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Kenya, South Korea, Libya, Lithuania, Malaysi
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2284-2023, Z-2283-2023

Azurion 7 M20. X-ray Image guided Therapy System.
Allura Xper FD10 and FD20. X-ray Imaging System.

Ongoing Class II Medical devices

Recall started: 21 March 2023
Reason: Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
Distribution: Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Dominican Rep Ecuador Egypt Estonia Finland France French Polynesia Germany Greece
Initiated: Voluntary: Firm initiated
Recall number: Z-1647-2023

Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azur

Ongoing Class II Medical devices

Recall started: 20 February 2023
Reason: There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1416-2023, Z-1417-2023

SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1

Ongoing Class II Medical devices

Recall started: 2 December 2021
Reason: Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.
Distribution: Domestic distribution to AZ CA FL GA HI IL KS KY MA MD ME MI MN MS NC NE NJ NV NY OH PA TN TX VA WA WV. Worldwide foreign distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0647-2022, Z-0649-2022, Z-0648-2022

Zenition 50, Model #718096
Veradius Unity, Model #718132
Zenition 70, Model #718133

Ongoing Class II Medical devices

Recall started: 26 May 2021
Reason: In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.
Distribution: US Nationwide and Worldwide Distribution
Initiated: FDA Mandated
Recall number: Z-0886-2022

Azurion systems with software release R1.x

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.