Philips Brilliance 16 CT Systems Recalled for Software Defect
Philips Medical Systems is recalling 203 Brilliance 16 CT 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 illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 203 units of the Brilliance 16 Computed Tomography X-ray systems. The recall is due to a software defect that causes an intermittently slow response of the Host.
The affected systems were distributed to numerous states across the United States and to many countries internationally. The specific serial numbers for the affected units are listed in the official recall documentation.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the software defect. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Brilliance 16 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
- 203
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 #: 728246
- Serial #s: 3010
- 3017
- 3031
- 3040
- 3043
- 3070
- 3072
- 3085
- 3090
- 3117
- 3123
- 3149
- 3179
- 3216
- 3247
- 3293
- 3314
- 3324
- 3411
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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