Philips Brilliance 16 Slice CT Scanner Recalled for Gantry Cover Separation Risk
Philips Medical Systems is recalling 6,343 Brilliance 16 Slice CT scanners 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 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 is classified as FDA Class II and involves a structural defect (falling gantry cover) that poses a risk of physical injury, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 6,343 units of the Brilliance 16 Slice (Power) Computed Tomography X-ray systems, Model 728240. 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 conducted because there is a potential for separation of the 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 specific CT scanners should contact Philips Medical Systems for instructions on how to address the potential defect. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Brilliance 16 Slice (Power), Model 728240 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…
- 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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