Philips Brilliance CT Scanners Recalled for Footswitch Cover Defect
Philips is recalling Brilliance CT scanners because the footswitch cover may impinge on the footswitch, causing the patient support to move unexpectedly.
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 (medical device) where injury has not yet been reported, which corresponds to a High severity score under the rubric.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling specific models of Brilliance CT scanners, including the Brilliance CT 6, 16, 40, and 64. The recall involves 309 units distributed worldwide, including in the United States and numerous international locations.
The recall is due to a defect where the footswitch cover may impinge on the footswitch. This impingement can cause the patient support to move in an unintended manner. The affected units are identified by specific model and serial numbers listed in the official recall documentation.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — CT Scanner
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model #
- 728231
- Serial #: 4021
- 9535
- 9544
- 9587
- 9627
- 9701
- 9707
- 9713
- 9759
- 9875
- 9887
- 9917
- 9925
- 9931
- 9980
- 9996
- 10009
- 10011
Distribution
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