Philips Brilliance 64 CT Systems Recalled for Software Defect
Philips Medical Systems is recalling 318 Brilliance 64 Computed Tomography X-ray systems due to a software defect causing intermittently slow response of the Host.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths. The hazard is a functional software defect (slow response) rather than a direct physical safety risk like fire or shock, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 318 units of the Brilliance 64 Computed Tomography X-ray system. The recall is due to a software defect that causes an intermittently slow response of the Host. The product is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
The affected units were distributed to 48 U.S. states and the District of Columbia, as well as numerous countries including Canada, the United Kingdom, Germany, and Japan. The specific model number is 728231, and the recall covers a specific list of serial numbers provided in the agency's documentation.
No injuries or illnesses have been reported in connection with this defect. Users should contact Philips Medical Systems for further instructions on how to resolve the software issue.
The recalled product
- Product
- Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 318
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 #s: 9009
- 9029
- 9033
- 9037
- 9038
- 9043
- 9045
- 9051
- 9052
- 9056
- 9058
- 9064
- 9065
- 9067
- 9068
- 9070
- 9072
- 9073
- 9075
Distribution
Part of a larger recall action
This product is one of 7 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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