Manufacturer

Philips Medical Systems (Cleveland), Inc.

315 recalls in our database name Philips Medical Systems (Cleveland), Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 315
Critical: 0
Severe: 26
Most recent: 2025-09-24

Of the 315 recalls from Philips Medical Systems (Cleveland), Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 26 (8%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 315

HighFDA (Devices)·Z-2570-2025·2025-09-24
Radiation planning software recalled over image errors in three patient orientations
Pinnacle Radiation Therapy Planning System software is recalled because of a potential image error of the Region of Interest for expansion or contraction in head first prone, feet first supine and feet first prone orientations.
Product
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)16.2.0.60010 Pinnacle TumorLOC 16.2.1 Model 870227 UDI c
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2239-2025·2025-08-13
Pinnacle 3 radiation planning software may miscalculate stopping power ratio
Pinnacle 3 with TumorLOC Radiation Therapy Planning System software is being recalled because a software issue may provide incorrect dataset calculations when performing the Stopping Power Ratio. 149 serial numbers affected.
Product
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System Software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1744-2022·2022-09-21
Pinnacle3 Radiation Therapy Planning System dose-calculation software error
Philips Pinnacle3 radiation therapy planning systems may export incorrect dose information when multiple beams are used with certain Edit Prescription settings. 169 systems are affected.
Product
Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.
Category
Medical Device
Distribution
21 states
SevereFDA (Devices)·Z-0215-2020·2019-11-13
Philips Forte Gamma Camera System Recalled for Detector Fall Hazard
Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded to the end stops.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0216-2020·2019-11-13
Philips Forte Gamma Camera System Recalled for Falling Detector Hazard
Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall vertically to the end stops of its travel limit.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0217-2020·2019-11-13
Philips Forte Gamma Camera System Recalled Due to Detector Falling Hazard
Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded to the end stops of its travel limit.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0214-2020·2019-11-13
Philips Recalls Forte Gamma Camera Systems Due to Detector Fall Risk
Philips Medical Systems is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded to the end stops of its travel limit.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0213-2020·2019-11-13
Philips Forte Gamma Camera System Recalled for Detector Fall Hazard
Philips is recalling 1,167 Forte Gamma Camera Systems because a detector may fall unimpeded vertically to the end stops of its travel limit.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2192-2019·2019-08-14
Philips IQon Spectral CT Recall for Cardiac Image Labeling Error
Philips is recalling 25 IQon Spectral CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Product
IQon Spectral CT Model # 728332, computed tomography x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2193-2019·2019-08-14
Philips Ingenuity TF PET/CT Recalled for Cardiac Image Labeling Error
Philips is recalling 12 Ingenuity TF PET/CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Product
Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2186-2019·2019-08-14
Philips Ingenuity CT Recalled for Potential Cardiac Image Labeling Error
Philips is recalling 92 Ingenuity CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Product
Ingenuity CT, Model # 728326, computed tomography x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2189-2019·2019-08-14
Philips iCT Computed Tomography System Recalled for Image Labeling Error
Philips is recalling 128 iCT computed tomography systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Product
iCT, Model # 728306, computed tomography x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2187-2019·2019-08-14
Philips CT System Recall for Incorrect Cardiac Image Labeling
Philips is recalling 116 CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Product
Ingenuity Core128 Model # 728323, computed tomography x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2188-2019·2019-08-14
Philips CT System Recall for Incorrect Phase Tolerance Image Labeling
Philips is recalling Ingenuity Core CT systems because images may be incorrectly labeled as having phase tolerance applied when it was not.
Product
Ingenuity Core Model # 728321, computed tomography x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2190-2019·2019-08-14
Philips iCT SP Computed Tomography Systems Recalled for Image Labeling Error
Philips is recalling 27 iCT SP computed tomography systems because images may be incorrectly labeled as having phase tolerance applied when it was not.
Product
iCT SP Model # 728311, computed tomography x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2194-2019·2019-08-14
Philips Recalls Vereos PET/CT Systems Due to Image Labeling Error
Philips is recalling 26 Vereos PET/CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Product
Vereos PET/CT Model # 882446, computed tomography x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2191-2019·2019-08-14
Philips Brilliance 64 CT System Recalled for Image Labeling Error
Philips is recalling 582 Brilliance 64 CT systems because images may be incorrectly labeled as having phase tolerance applied when it was not.
Product
Brilliance 64 Model # 728231, computed tomography x-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2010-2019·2019-07-31
Philips BrightView X Handcontroller Recall for Uncommanded Motion Risk
Philips Medical Systems is recalling 117 BrightView X devices because a handcontroller issue may cause spontaneous or continued motion.
Product
BrightView X , Model Number 882478
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2011-2019·2019-07-31
Philips BrightView XCT Medical Device Recalled for Handcontroller Motion Defect
Philips Medical Systems is recalling 427 BrightView XCT devices because a handcontroller issue may cause uncommanded motions or continued motion after buttons are released.
Product
BrightView XCT , Model Number 882482
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2009-2019·2019-07-31
Philips BrightView SPECT Recalled for Uncommanded Handcontroller Motion
Philips Medical Systems is recalling 696 BrightView SPECT units because the handcontroller may move spontaneously or continue moving after buttons are released.
Product
BrightView SPECT, Model Number 882480
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1929-2019·2019-07-10
Philips Recalls Vereos PET/CT Systems Due to Cover Misalignment
Philips Medical Systems is recalling 70 Vereos PET/CT systems because misaligned covers may create gaps or protrude into the imaging bore.
Product
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 transmission data. The PET subsystem images the distribution of
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1144-2019·2019-04-24
Philips Brilliance iCT CT Scanners Recalled for Collimator Compensator Failure
Philips is recalling two Brilliance iCT CT scanners because a component may fail, causing image artifacts. The devices were distributed only to China and the UK.
Product
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 planes. This device may include signal analysis and display equip
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1142-2019·2019-04-24
Philips Brilliance 16 Air CT Systems Recalled for Collimator Defect
Philips is recalling 23 Brilliance 16 Air CT systems because a collimator component may fail, causing image artifacts.
Product
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 planes. This device may include signal analysis and display eq
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1143-2019·2019-04-24
Philips Brilliance 64 CT Systems Recalled for Image Artifacts
Philips is recalling 14 Brilliance 64 CT systems because a component may fail, causing ring or smudge artifacts on images.
Product
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. This device may include signal analysis and display equipm
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0823-2019·2019-02-20
Philips Ingenuity TF PET/CT Software Update Corrects Multiple Issues
Philips is issuing a software update for 24 Ingenuity TF PET/CT systems to correct multiple issues identified in the previous software version.
Product
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 cross-sectional images of the body by computer reconstruction o
Category
Medical Device
Distribution
Distributed nationwide