Philips Brilliance 64 CT Scanner Recall for Gantry Cover Separation Risk
Philips Medical Systems is recalling Brilliance 64 CT scanners due to a potential fiberglass resin separation that could cause the gantry front cover to fail and fall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (falling equipment) where injury has not yet been reported, which aligns with the High severity criteria for theoretical hazards without confirmed harm.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 6,343 units of the Brilliance 64, Model 728231, Computed Tomography X-ray systems. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data. The recall covers units distributed nationwide in the United States.
The recall is being issued because there is a potential for separation of fiberglass resin. This separation may cause the gantry front cover and the metal support on the cover to fail or fall. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities and users of these devices should contact Philips Medical Systems for instructions on how to address the potential safety hazard. The recall is classified as Class II by the FDA.
The recalled product
- Product
- 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 planes. These devices may include signal analysts and…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 6,343
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Philips Medical Systems (Cleveland) Inc
See all →- HighRadiation planning software recalled over image errors in three patient orientations
FDA (Devices) · 2025-09-24
- HighPinnacle 3 radiation planning software may miscalculate stopping power ratio
FDA (Devices) · 2025-08-13
- HighPinnacle3 Radiation Therapy Planning System dose-calculation software error
FDA (Devices) · 2022-09-21
- SeverePhilips Forte Gamma Camera System Recalled Due to Detector Falling Hazard
FDA (Devices) · 2019-11-13
- SeverePhilips Recalls Forte Gamma Camera Systems Due to Detector Fall Risk
FDA (Devices) · 2019-11-13
Same hazard · falling object
See all →- SevereLithonia Lighting Recalls RSX Luminaires with Adjustable Tilt Arms
CPSC · 2026-10-22
- HighMaquet PowerLED 300 Concealed Lighting System Recalled for Detachment Risk
FDA (Devices) · 2026-09-30
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- SevereTerex Digger Derrick Trucks Recalled for Weld Defect
NHTSA · 2026-08-17
Similar recalls
- ModeratePhilips Brilliance 64 CT Scanner Recalled for Image Reconstruction Errors
FDA (Devices) · 2016-08-31
- HighPhilips Brilliance 64 CT System Recalled for Software Defects
FDA (Devices) · 2015-12-16
- ModeratePhilips Brilliance 64 CT Scanner Software Recall
FDA (Devices) · 2016-08-17
- HighPhilips Brilliance 64 CT System Recalled for Emergency Stop Defect
FDA (Devices) · 2018-04-25
- HighPhilips Brilliance 64 CT Systems Recalled for Software Error
FDA (Devices) · 2016-12-14
- ModeratePhilips Brilliance 64 CT Scanner Recall for Image Artifacts
FDA (Devices) · 2016-07-06