Cleveland, OH, United States
Philips Medical Systems (Cleveland) Inc recalls
27 recalls recorded since 2018, most recently on 5 August 2025. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls27
Ongoing (FDA)3
Terminated or completed24
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 5 August 2025
- Reason
- Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
- Distribution
- U.S Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2570-2025
- Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)00884838103566(10)18.0.5.22236 Pinnacle TumorLOC 16.2 Model 870226 UDI code: (01)00884838091122(10)
Ongoing Class II Medical devices
- Recall started
- 17 July 2025
- Reason
- Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
- Distribution
- Worldwide - US Nationwide distribution in the state of WV and the countries of Macao & United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2239-2025
- Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Ongoing Class II Medical devices
- Recall started
- 30 August 2022
- Reason
- When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.
- Distribution
- Distribution was made to CA, FL, GA, IA, IL, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, OK, RI, SC, TN, TX, and WA. There was government distribution and no military distribution. Foreign distribution was made to Australia, Austria, Belgium, China, France, Germany, Italy, Japan, Jordan, Lebanon, Pola
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1744-2022
- Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Terminated Class I Medical devices
- Recall started
- 19 September 2019
- Terminated
- 5 April 2021
- Reason
- An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
- Distribution
- Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0217-2020, Z-0216-2020, Z-0213-2020, Z-0215-2020, Z-0214-2020
- Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
- Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
- Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
- Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
- Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
Terminated Class II Medical devices
- Recall started
- 24 June 2019
- Terminated
- 6 October 2022
- Reason
- In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Canada, Mexico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Cote D'Ivoir
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2187-2019, Z-2191-2019, Z-2189-2019, Z-2186-2019, Z-2193-2019, Z-2190-2019, Z-2188-2019, Z-2194-2019, Z-2192-2019
- Ingenuity Core128 Model # 728323, computed tomography x-ray system
- Brilliance 64 Model # 728231, computed tomography x-ray system
- iCT, Model # 728306, computed tomography x-ray system
- Ingenuity CT, Model # 728326, computed tomography x-ray system
- Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
- iCT SP Model # 728311, computed tomography x-ray system
- Ingenuity Core Model # 728321, computed tomography x-ray system
- Vereos PET/CT Model # 882446, computed tomography x-ray system
- and 1 more product lines
Terminated Class II Medical devices
- Recall started
- 10 June 2019
- Terminated
- 24 July 2020
- Reason
- An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
- Distribution
- Worldwide Distribution - US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2011-2019, Z-2009-2019, Z-2010-2019
- BrightView XCT , Model Number 882482
- BrightView SPECT, Model Number 882480
- BrightView X , Model Number 882478
Terminated Class II Medical devices
- Recall started
- 3 June 2019
- Terminated
- 26 April 2021
- Reason
- The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cover parts and/or protrusion of the cover into the bore diameter.
- Distribution
- Worldwide Distribution - US Nationwide Domestic distribution to CA GA LA MD MI MN MO NE NJ NY OH TN TX VT WI. Foreign distribution to Mexico, Argentina Austria Belgium China Colombia France Germany Israel Italy Japan Latvia Luxembourg Netherlands Portugal Singapore
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1929-2019
- Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray tran
Terminated Class II Medical devices
- Recall started
- 19 December 2018
- Terminated
- 3 August 2021
- Reason
- A software update is being issued to correct multiple issues identified in the previous software version.
- Distribution
- Worldwide distribution: US (nationwide) to states of: CA, IL, NY, OH, and PA; and to countries of: Australia, Austria, Columbia, Egypt, France, Germany, India, Italy, Lithuania, Netherlands, and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0823-2019
- Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cro
Terminated Class II Medical devices
- Recall started
- 18 October 2018
- Terminated
- 3 August 2021
- Reason
- There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0548-2019, Z-0544-2019, Z-0545-2019, Z-0543-2019, Z-0547-2019, Z-0546-2019
- Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different
- Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and
- Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at differe
- Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and
- Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different
- Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different
Terminated Class II Medical devices
- Recall started
- 4 September 2018
- Terminated
- 5 May 2020
- Reason
- Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures; and Software errors that may result in partial set of images, inability to generate CT or PET images, incorrect scan parameters, or scanning the incorrect portion of the body.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0302-2019
- Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomogr
Terminated Class II Medical devices
- Recall started
- 3 July 2018
- Terminated
- 17 April 2020
- Reason
- Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
- Distribution
- Distributed only to China and UK.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1142-2019, Z-1144-2019, Z-1143-2019
- Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and pl
- Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and plane
- Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
Terminated Class II Medical devices
- Recall started
- 21 May 2018
- Terminated
- 10 April 2020
- Reason
- The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw may be misaligned in the patient pallet.
- Distribution
- Worldwide Distribution - US Nationwide in the states of CA, GA, LA, MD, MI, NY, OH, TN, TX, VT, Washington DC & WI Internationally - Canada, Mexico, Belgium, France, Israel, Luxembourg, Netherlands, Singapore, Spain & Switzerland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2496-2018
- Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)9000
Terminated Class II Medical devices
- Recall started
- 30 March 2018
- Terminated
- 14 April 2020
- Reason
- The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
- Distribution
- Worldwide distribution including US states of CA, MD, NV, OH, TX, and WI, Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2175-2018, Z-2176-2018, Z-2174-2018
- Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
- Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
- Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system
Terminated Class II Medical devices
- Recall started
- 28 March 2018
- Terminated
- 21 April 2020
- Reason
- A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
- Distribution
- The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2273-2018, Z-2274-2018, Z-2275-2018, Z-2276-2018, Z-2277-2018
- Brilliance Big Bore Radiology 728244
- Philips Ingenuity Core 728321
- Ingenuity Core128 728323
- Ingenuity TF PET/CT 882442
- Ingenuity Core128/Elite China 728324
Terminated Class II Medical devices
- Recall started
- 21 February 2018
- Terminated
- 10 April 2020
- Reason
- Surview scan with tube current lower than 30 mA is unable to be initialized.
- Distribution
- Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1396-2018
- Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmis
Terminated Class II Medical devices
- Recall started
- 15 February 2018
- Terminated
- 21 November 2019
- Reason
- Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.
- Distribution
- Worldwide Distribution - US Nationwide in the states of: OH and OR, and Foreign distribution to Australia, China, Cuba, France, and South Africa.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1392-2018
- Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applica
Terminated Class II Medical devices
- Recall started
- 8 February 2018
- Terminated
- 9 April 2020
- Reason
- Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- Distribution
- Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republ
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1411-2018, Z-1406-2018, Z-1412-2018, Z-1407-2018, Z-1404-2018, Z-1405-2018, Z-1413-2018, Z-1414-2018, Z-1408-2018, Z-1415-2018, Z-1409-2018, Z-1410-2018
- Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction
- Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmissi
- Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-r
- Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-
- Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmis
- Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray tr
- Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmiss
- IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transm
- and 4 more product lines
Terminated Class II Medical devices
- Recall started
- 11 January 2018
- Terminated
- 20 May 2019
- Reason
- 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.
- Distribution
- Domestic and Foreign
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0841-2018
- IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Terminated Class II Medical devices
- Recall started
- 3 January 2018
- Terminated
- 2 July 2019
- Reason
- Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the CT simulation Exam Card; Software errors that may result in Tumor LOC allowing POI (Point of Interest) locking when a non-isocenter slice is displayed; Software errors that may result in partial set of images or inability to generate CT images.
- Distribution
- Worldwide Distribution - US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0840-2018, Z-0839-2018
- Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray
- Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ra
Terminated Class II Medical devices
- Recall started
- 15 December 2017
- Terminated
- 10 April 2020
- Reason
- During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
- Distribution
- Worldwide Distribution - US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0512-2018, Z-0513-2018, Z-0511-2018, Z-0510-2018, Z-0514-2018
- BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. Th
- Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system.
- BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging comp
- BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies
- Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system.
Terminated Class II Medical devices
- Recall started
- 11 December 2017
- Terminated
- 30 August 2022
- Reason
- A software issue causes PET reconstructions to fail intermittently. It was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual table position. This error has been found to occur in two scenarios: 1) When the system operator cancels an acquisition a. The error will occur every time a scan is cancelled by the operator. 2) Couch position requests within the software sequence were delayed a. The error occurs intermittently, but has been found to occur more frequently when the gantry s network is heavily loaded with multiple retrospective reconstructions running in parallel. b. The error manifests to the technologist by an error message and Failed status on the Reconstruction Monitor and the error message Result {0} failed to reconstruct" on the Acquisition Workflow window during reconstruction after the patient scan has been completed. In both scenarios, the acquisition data will not be able to be reconstructed and will therefore be unusable.
- Distribution
- Worldwide Distribution - US Distribution to the states of : CA, OH, IL, PA and NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0562-2018
- Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsys
Terminated Class II Medical devices
- Recall started
- 10 November 2017
- Terminated
- 5 November 2020
- Reason
- Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
- Distribution
- Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0391-2018, Z-0388-2018, Z-0390-2018, Z-0389-2018
- Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Terminated Class II Medical devices
- Recall started
- 8 November 2017
- Terminated
- 17 April 2020
- Reason
- There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
- Distribution
- 107 domestic accounts 15 US Govt accounts 682 Foreign Accounts 3 Mexico accounts 12 Canada accounts
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0331-2018, Z-0332-2018, Z-0333-2018
- Philips Healthcare Brilliance iCT computed tomography x-ray system
- Philips Healthcare Brilliance iCT SP computed tomography x-ray system
- Philips Healthcare IQon Spectral CT computed tomography x-ray system
Terminated Class II Medical devices
- Recall started
- 1 November 2017
- Terminated
- 14 August 2018
- Reason
- One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
- Distribution
- One domestic and 1 foreign consignee ( Spain)
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0522-2018
- Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
Terminated Class II Medical devices
- Recall started
- 6 October 2017
- Terminated
- 2 July 2019
- Reason
- Numerous issues related to software Brilliance iCT 4.1.6 software version.
- Distribution
- 26 US Govt accounts
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0518-2018, Z-0519-2018, Z-0521-2018, Z-0520-2018
- Philips Brilliance 64 computed tomography x-ray system
- Philips Ingenuity Core computed tomography x-ray system
- Philips Ingenuity CT computed tomography x-ray system
- Philips Ingenuity Core 128 computed tomography x-ray system
Terminated Class II Medical devices
- Recall started
- 11 July 2017
- Terminated
- 2 July 2019
- Reason
- Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
- Distribution
- Worldwide distribution, including US nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0403-2018, Z-0402-2018
- Brilliance iCT - Model 728306 Computed Tomography X-ray systems
- Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Terminated Class II Medical devices
- Recall started
- 7 June 2017
- Terminated
- 3 July 2019
- Reason
- It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0306-2019, Z-0309-2019, Z-0307-2019, Z-0308-2019, Z-0310-2019, Z-0304-2019, Z-0311-2019, Z-0303-2019, Z-0305-2019
- IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmi
- Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data
- Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray t
- Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data ta
- Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission d
- Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data t
- Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmiss
- Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray tr
- and 1 more product lines
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.