Philips Brilliance 64 CT Systems Recalled for Software Data Transmission Error
Philips Medical Systems is recalling 285 Brilliance 64 CT systems because a software error may prevent the automatic transmission of all image and data series to remote devices.
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. The hazard involves a software error that may prevent the automatic transmission of data to remote devices, which is a functional defect rather than a direct physical safety hazard like fire or shock. No injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling 285 units of the Brilliance 64 Computed Tomography X-ray System. 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 was initiated after the firm was notified of a software error. This error may cause the system to fail to automatically send all image and data series to remote devices. The affected units were distributed worldwide, including in the United States and numerous international locations.
Healthcare facilities and users should contact Philips Medical Systems for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Brilliance 64:Computed Tomography X-ray Systems, 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
- Affected units
- 285
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
- S/N: 1
- 2
- 4001
- 9056
- 9074
- 9099
- 9134
- 9251
- 9515
- 9529
- 9538
- 9549
- 9554
- 9573
- 9574
- 9618
- 9625
- 9638
- 9646
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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