Philips Brilliance 6 Slice CT Scanner Recalled for Gantry Cover Separation Risk
Philips Medical Systems is recalling Brilliance 6 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover to fail or 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, fitting the 'High' severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 6,343 units of the Brilliance 6 Slice (Air) Computed Tomography (CT) X-ray systems, Model 728256. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data.
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.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect. Specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- Brilliance 6 Slice (Air), Model 728256 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
- 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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