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.

51–75 of 315

SevereFDA (Devices)·Z-1411-2018·2018-04-25
Philips Brilliance Big Bore CT Systems Recalled for Emergency Stop Defect
Philips is recalling 119 Brilliance Big Bore CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient load or unload.
Product
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 of X-ray transmission data taken at different angles and pla
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1409-2018·2018-04-25
Philips Brilliance iCT SP CT Systems Recalled for Emergency Stop Defect
Philips is recalling 19 Brilliance iCT SP CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
Brilliance iCT SP - Model no. 728311 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 transmission data taken at different angles and planes. These devi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2018·2018-04-25
Philips Brilliance 64 CT System Recalled for Emergency Stop Defect
Philips Medical Systems is recalling six Brilliance 64 CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
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 transmission data taken at different angles and planes. These devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1407-2018·2018-04-25
Philips Ingenuity Core 128 CT Systems Recalled for Emergency Stop Defect
Philips is recalling 591 Ingenuity Core 128 CT systems because closing the emergency stop may allow the patient couch to move during loading or unloading.
Product
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-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1406-2018·2018-04-25
Philips Ingenuity Core CT Systems Recalled for Couch Movement Hazard
Philips is recalling 281 Ingenuity Core CT systems because the emergency stop may fail to lock the couch, allowing it to move during patient loading.
Product
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 transmission data taken at different angles and planes. These devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2018·2018-04-25
Philips Brilliance iCT CT Systems Recalled for Emergency Stop Defect
Philips is recalling 295 Brilliance iCT CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
Brilliance iCT - Model no. 728306 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 transmission data taken at different angles and planes. These devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1414-2018·2018-04-25
Philips IQon Spectral CT Recalled for Emergency Stop Defect
Philips is recalling 47 IQon Spectral CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
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 transmission data taken at different angles and planes. These devi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1404-2018·2018-04-25
Philips Ingenuity Flex CT Scanner Recall for Emergency Stop Defect
Philips is recalling 151 Ingenuity Flex CT scanners because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
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 transmission data taken at different angles and planes. These device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1396-2018·2018-04-25
Philips Brilliance 64 CT Scanner Software Defect Recall
Philips is recalling 291 Brilliance 64 CT scanners because a software defect prevents Surview scans from initializing when tube current is below 30 mA.
Product
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 transmission data taken at different angles and planes. These device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1405-2018·2018-04-25
Philips Ingenuity CT Recall for Emergency Stop Defect
Philips is recalling 172 Ingenuity CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient load or unload.
Product
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 transmission data taken at different angles and planes. These
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1410-2018·2018-04-25
Philips CT Scanner Recall Due to Emergency Stop Defect
Philips is recalling 106 Brilliance Big Bore CT scanners because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading or unloading.
Product
Brilliance Big Bore (Oncology) - Model no. 728243, 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 transmission data taken at different angles and plan
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1415-2018·2018-04-25
Philips Brilliance 6 Slice CT System Recalled for Emergency Stop Defect
Philips is recalling Brilliance 6 Slice CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
Brilliance 6 Slice (Air) - Model no. 728256, 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 transmission data taken at different angles and planes. Th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1412-2018·2018-04-25
Philips Brilliance 16 Slice CT System Recalled for Emergency Stop Defect
Philips is recalling two Brilliance 16 Slice CT systems because the emergency stop may fail to disable the horizontal motor, allowing the couch to move during patient loading.
Product
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-ray transmission data taken at different angles and planes. T
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1392-2018·2018-04-25
Philips Ingenuity TF PET/CT Recalled for Unresponsive Acquisition Console
Philips is recalling 12 Ingenuity TF PET/CT systems because the mass storage device may cause the acquisition console to become unresponsive, preventing image acquisition.
Product
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 applications. The device utilizes the CT technology to obtain anato
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0839-2018·2018-03-14
Philips Brilliance Big Bore CT Software Recall for Image Generation Errors
Philips is recalling 119 Brilliance Big Bore CT scanners due to software errors that may prevent image generation or display incorrect settings.
Product
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-ray transmission data taken at different angles and planes. Th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0840-2018·2018-03-14
Philips Recalls Brilliance Big Bore Oncology CT Scanners Due to Software Errors
Philips Medical Systems is recalling 11 Brilliance Big Bore Oncology CT scanners due to software errors that may affect image generation and display settings.
Product
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 transmission data taken at different angles and planes. The
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0841-2018·2018-03-14
Philips IQon Spectral CT Software Recall for Image Misrepresentation
Philips is recalling 63 IQon Spectral CT systems due to software errors that may cause image misrepresentation or failure to generate images.
Product
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0562-2018·2018-02-21
Philips Ingenuity TF PET/CT Software Recall for Reconstruction Failures
Philips is recalling 24 Ingenuity TF PET/CT systems due to a software defect that causes intermittent PET reconstruction failures, rendering acquired data unusable.
Product
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 subsystem produces cross-sectional images of the body by computer
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0514-2018·2018-02-14
Philips Precedence 16 Imaging System Recalled for Collimator Drop Risk
Philips is recalling 1,387 Precedence 16 imaging systems because collimators may drop to the floor during exchange, posing a physical hazard.
Product
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. Precedence may produce non-attenuation corrected and attenu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0511-2018·2018-02-14
Philips BrightView XCT Gamma Camera Recalled for Collimator Drop Risk
Philips Medical Systems is recalling BrightView XCT gamma cameras because a collimator may drop to the floor during exchange, posing a risk of injury.
Product
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 components. BrightView XCT produces non-attenuation corrected SP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0512-2018·2018-02-14
Philips BrightView Gamma Cameras Recalled for Collimator Drop Risk
Philips Medical Systems is recalling BrightView Model 882480 gamma cameras because collimators may drop to the floor during exchange, posing a physical hazard.
Product
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. The cameras can be used to perform planar static, dynamic, gat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0510-2018·2018-02-14
Philips BrightView X Gamma Cameras Recalled for Collimator Drop Risk
Philips Medical Systems is recalling BrightView X gamma cameras because collimators may drop to the floor during exchange, posing a physical hazard.
Product
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. The cameras can be used to perform planar static, dynamic,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0513-2018·2018-02-14
Philips Precedence 6 Imaging System Recalled for Collimator Drop Risk
Philips is recalling 1,387 Precedence 6 imaging systems because collimators may drop to the floor during exchange, posing a risk of injury.
Product
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. Precedence may produce non-attenuation corrected and attenua
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0520-2018·2018-02-14
Philips CT System Recalled for Software Issues
Philips Medical Systems is recalling Ingenuity Core 128 CT systems due to software issues in version 4.1.6.
Product
Philips Ingenuity Core 128 computed tomography x-ray system
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0521-2018·2018-02-14
Philips Ingenuity CT System Recalled for Software Issues
Philips Medical Systems is recalling Ingenuity CT systems due to software issues in version 4.1.6. The recall affects 26 US government accounts.
Product
Philips Ingenuity CT computed tomography x-ray system
Category
Medical Device
Distribution
0 states