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.
What this means for you
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 displ
- 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.
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