Philips Brilliance iCT Recalled for Software Performance Issues
Philips Medical Systems is recalling 335 Brilliance iCT units due to software issues in versions v4.1.3 and v4.1.5 that could affect equipment performance.
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 describes a potential performance issue without reporting specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 335 units of the Brilliance iCT, Model No. 728306. The recall is due to software issues in versions v4.1.3 and v4.1.5 that could affect the performance of the equipment.
The affected products were shipped to 48 U.S. states and numerous countries worldwide. The source text does not specify the exact nature of the performance degradation or report any specific injuries or illnesses associated with the defect.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issue. Consumers are advised to check if their facility has received the recall notice and follow the manufacturer's guidance.
The recalled product
- Product
- Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 335
Distribution
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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