Philips Brilliance CT 16 Power Systems Recalled for Software Defect
Philips Medical Systems is recalling 55 Brilliance CT 16 Power 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 defect involves a performance issue (slow response) rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 55 units of the Brilliance CT 16 Power Computed Tomography X-ray systems. These systems are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
The recall is due to a software defect that causes intermittently slow response of the Host. The affected units were distributed to 48 U.S. states and the District of Columbia, as well as numerous countries worldwide. Specific serial numbers for the affected units are listed in the recall documentation.
Healthcare facilities and consumers should contact Philips Medical Systems for further instructions regarding the recall and remediation of the software defect.
The recalled product
- Product
- Brilliance CT 16 Power 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
- 55
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 #: 728240
- Serial #s: 3100
- 3236
- 5043
- 5047
- 5280
- 5345
- 5390
- 5395
- 5413
- 5430
- 5476
- 5495
- 5499
- 5500
- 5512
- 6007
- 6009
- 6013
- 6032
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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