Philips Brilliance 64 CT Scanner Software Recall
Philips is recalling Brilliance 64 CT scanners due to software issues 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 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 150 units of the Brilliance 64 CT Model 728231. The recall is due to software issues found in versions v4.1.3, v4.1.4, 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 recall covers specific serial numbers listed in the agency's documentation.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software issues.
The recalled product
- Product
- Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — CT Scanner
- Hazard
- Affected units
- 150
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 No. 728231
- Brilliance 64 CT S/N: 9099
- 9134
- 9251
- 9515
- 9646
- 9822
- 9898
- 9983
- 10099
- 10180
- 10206
- 10208
- 91003
- 95130
- 95157
- 95387
- 95504
- 4001
- 9056
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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