Philips Brilliance 40 CT Systems Recalled for Gantry Cover Separation Risk
Philips is recalling 6,343 Brilliance 40 CT systems nationwide due to a potential fiberglass resin separation that could cause the gantry front cover to 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device where a component (gantry cover) could fail and fall, posing a risk of significant injury, which aligns with the 'Severe' criteria for structural defects or significant injury reports.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 6,343 Brilliance 40 Computed Tomography (CT) X-ray systems, Model 728235. The recall is due to a potential for separation of fiberglass resin, which may cause the gantry front cover and the metal support on the cover to fail or fall.
The affected units were distributed nationwide in the United States. The source text does not specify the exact date of the recall or the specific serial numbers affected, though the structured data lists numerous system serial numbers.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. The source text does not provide specific consumer instructions or a hotline number.
The recalled product
- Product
- Brilliance 40, Model 728235 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.
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