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Philips Medical Systems (Cleveland) Recalls

315 recalls on record · June 20, 2012 to September 24, 2025 · Medical Devices

Recalls by year

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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

September 24, 2025Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code: (01)008
Hazard: 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.
August 13, 2025Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Hazard: Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
September 21, 2022Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Hazard: 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.
November 13, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and posit
Hazard: 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.
November 13, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and posit
Hazard: 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.
November 13, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and posit
Hazard: 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.
November 13, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and posit
Hazard: 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.
November 13, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and posit
Hazard: 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.
August 14, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Vereos PET/CT Model # 882446, computed tomography x-ray system
Hazard: 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
August 14, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
Hazard: 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
August 14, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls IQon Spectral CT Model # 728332, computed tomography x-ray system
Hazard: 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
August 14, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 64 Model # 728231, computed tomography x-ray system
Hazard: 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
August 14, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls iCT SP Model # 728311, computed tomography x-ray system
Hazard: 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
August 14, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls iCT, Model # 728306, computed tomography x-ray system
Hazard: 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
August 14, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core Model # 728321, computed tomography x-ray system
Hazard: 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
August 14, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core128 Model # 728323, computed tomography x-ray system
Hazard: 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
August 14, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity CT, Model # 728326, computed tomography x-ray system
Hazard: 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
July 31, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView XCT , Model Number 882482
Hazard: An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
July 31, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView X , Model Number 882478
Hazard: An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
July 31, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls BrightView SPECT, Model Number 882480
Hazard: An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
July 10, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT)
Hazard: 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.
April 24, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images o
Hazard: 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.
April 24, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of
Hazard: 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.
April 24, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional image
Hazard: 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.
February 20, 2019Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron
Hazard: A software update is being issued to correct multiple issues identified in the previous software version.
December 12, 2018Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-se
Hazard: 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
December 12, 2018Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-s
Hazard: 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
December 12, 2018Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-s
Hazard: 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
December 12, 2018Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross
Hazard: 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
December 12, 2018Medical DevicesFDA
Philips Medical Systems (Cleveland) Inc recalls Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Ima
Hazard: 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
Philips Medical Systems (Cleveland) Recalls | RecallWatchUSA