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.

101–125 of 315

HighFDA (Devices)·Z-1005-2017·2017-01-18
Philips Clinix RF Plus X-ray System Recalled for Tilt Hazard
Philips is recalling 41 Clinix RF Plus X-ray systems because liquid penetration can cause an unintentional tilt of the diagnostic table.
Product
FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical regions. This device may include signal analysis and display equipment, patient and equipment supports, components and accessori
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1004-2017·2017-01-18
Philips Brilliance iCT CT System Recalled for Undocumented Installation
Philips Medical Systems is recalling one Brilliance iCT system because the installation of four M12 bolts was not correctly documented.
Product
Brilliance iCT 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. These devices may include signal analysts and display equipment,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0696-2017·2016-12-14
Philips Ingenuity Core 128 MRI Software Recall for Timer Error
Philips Medical Systems is recalling 509 Ingenuity Core 128 MRI systems due to a software error involving the filament on timer.
Product
Ingenuity Core 128 728323
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-0693-2017·2016-12-14
Philips Brilliance 64 CT Systems Recalled for Software Error
Philips Medical Systems is recalling 184 Brilliance 64 CT systems worldwide due to a software error involving the filament on timer.
Product
Brilliance 64 728231 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. These devices may include signal analysis and display equipment, patient and
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-0706-2017·2016-12-14
Philips Spectral CT Software Recalled for Image Processing Defects
Philips Medical Systems is recalling Spectral CT software due to a defect causing issues with filming, saving, and annotating images.
Product
Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0697-2017·2016-12-14
Philips Ingenuity CT Systems Recalled for Software Timer Error
Philips Medical Systems is recalling 371 Ingenuity CT systems worldwide due to a software error involving the filament on timer.
Product
Ingenuity CT 728326 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. These devices may include signal analysis and display equipment, patient and e
Category
Medical Device
Distribution
46 states
ModerateFDA (Devices)·Z-0694-2017·2016-12-14
Philips Brilliance 64 CT Systems Recalled for Software Error
Philips Medical Systems is recalling 18 Brilliance 64 CT systems due to a software error involving the filament on timer.
Product
Brilliance 64 728232 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. These devices may include signal analysis and display equipment, patient and
Category
Medical Device
Distribution
46 states
ModerateFDA (Devices)·Z-0705-2017·2016-12-14
Philips IQon Spectral CT Software Defect Recall
Philips is recalling 24 IQon Spectral CT systems due to a software defect that causes issues with filming, saving, and annotating images.
Product
IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0695-2017·2016-12-14
Philips Ingenuity Core CT Systems Recalled for Software Error
Philips Medical Systems is recalling 337 Ingenuity Core CT systems worldwide due to a software error involving the filament on timer.
Product
Ingenuity Core 728321 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. These devices may include signal analysis and display equipment, patient and
Category
Medical Device
Distribution
46 states
LowFDA (Devices)·Z-0595-2017·2016-11-23
Philips Ingenuity CT System Recalled for Incorrect Label Rating
Philips is recalling 27 Ingenuity CT systems because the product labels do not include the correct current rating.
Product
Ingenuity CT Computed Tomography X-ray system, Model 728326
Category
Medical Device
Distribution
15 states
LowFDA (Devices)·Z-0596-2017·2016-11-23
Philips CT Scanner Recall for Incorrect Product Label Rating
Philips is recalling 15 Ingenuity Core 128 CT scanners because the product labels do not include the correct current rating.
Product
Ingenuity Core 128 Computed Tomography X-ray system, Model 728323
Category
Medical Device
Distribution
15 states
LowFDA (Devices)·Z-0594-2017·2016-11-23
Philips Brilliance CT System Recalled for Incorrect Label Rating
Philips is recalling three Brilliance ICT SP CT systems because the product labels do not include the correct current rating.
Product
Brilliance ICT SP Computed Tomography X-ray system, Model 728311
Category
Medical Device
Distribution
15 states
LowFDA (Devices)·Z-0593-2017·2016-11-23
Philips Brilliance iCT Computed Tomography System Recalled for Labeling Error
Philips Medical Systems is recalling 67 Brilliance iCT Computed Tomography X-ray systems because the product labels do not include the correct current rating.
Product
Brilliance iCT Computed Tomography X-ray system, Model 728306
Category
Medical Device
Distribution
15 states
LowFDA (Devices)·Z-0598-2017·2016-11-23
Philips IQon Spectral CT System Recalled for Incorrect Label Rating
Philips Medical Systems is recalling three IQon Spectral CT systems because the product labels do not include the correct current rating.
Product
IQon Spectral CT Computed Tomography X-ray system, Model 728332
Category
Medical Device
Distribution
15 states
LowFDA (Devices)·Z-0597-2017·2016-11-23
Philips CT System Recalled for Incorrect Label Rating
Philips is recalling two Ingenuity Core CT systems because the product labels do not include the correct current rating.
Product
Ingenuity Core Computed Tomography X-ray system, Model 728321
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-2737-2016·2016-09-14
Philips BrightView XCT Upgrade Recalled for Potential Patient Contact
Philips is recalling three BrightView XCT Upgrade units due to a software defect that may cause the detector to contact patients during specific scans.
Product
BrightView XCT Upgrade Model 882454
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2735-2016·2016-09-14
Philips BrightView X Gamma Camera Recalled for Software Defect
Philips Medical Systems is recalling 117 BrightView X gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.
Product
BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2736-2016·2016-09-14
Philips BrightView XCT Gamma Camera Recalled for Software Defect
Philips Medical Systems is recalling 424 BrightView XCT gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.
Product
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2658-2016·2016-08-31
Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Defect
Philips is recalling three Ingenuity Core128 CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scan images.
Product
Ingenuity Core128, Model number 728323 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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2657-2016·2016-08-31
Philips Ingenuity Core CT Systems Recalled for Image Reconstruction Defect
Philips is recalling 30 Ingenuity Core CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scans.
Product
Ingenuity Core, Model number 728321 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2652-2016·2016-08-31
Philips Brilliance 64 CT Scanner Recalled for Image Reconstruction Errors
Philips is recalling 283 Brilliance 64 CT scanners because a software update can cause planned anatomy to be cut off in images, potentially requiring a rescan.
Product
Brilliance 64 CT 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 transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2654-2016·2016-08-31
Philips Brilliance BigBore CT Scanner Recalled for Image Reconstruction Error
Philips is recalling 24 Brilliance BigBore CT scanners because a software upgrade can cause planned anatomy to be cut off in gated helical scan images.
Product
Brilliance BigBore Radiology CT Model number 728244 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2653-2016·2016-08-31
Philips Brilliance CT Big Bore Oncology Software Recall
Philips is recalling 33 Brilliance CT Big Bore Oncology systems due to a software defect that may cause planned anatomy to be cut off in gated helical CT images.
Product
Brilliance CT Big Bore Oncology, Model number 728243 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2655-2016·2016-08-31
Philips Brilliance 16 CT Scanner Recalled for Image Reconstruction Defect
Philips Medical Systems is recalling 192 Brilliance 16 CT scanners because a software upgrade can cause planned anatomy to be cut off in images, potentially requiring a rescan.
Product
Brilliance 16, Model number 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2656-2016·2016-08-31
Philips Brilliance CT 16 Power Software Defect Recall
Philips is recalling 50 Brilliance CT 16 Power systems due to a software defect that may cause planned anatomy to be cut off in images, potentially requiring a rescan.
Product
Brilliance CT 16 Power, Model number 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 different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide