Philips Brilliance 16 Slice CT Scanner Recall for Cover Separation
Philips is recalling Brilliance 16 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover to fail or 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 where a component may fail and fall, but the source text does not report any injuries or illnesses, meeting the criteria for a High severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 6,343 units of the Brilliance 16 Slice (Air) Computed Tomography X-ray system, Model 728246. The 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 (Cleveland) Inc for instructions on how to address the defect. The source text does not specify a remediation method or a deadline for the recall.
The recalled product
- Product
- Brilliance 16 Slice (Air), Model 728246 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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