Philips Recalls Brilliance 64 CT Systems Due to X-ray Measurement Error
Philips Medical Systems is recalling 108 Brilliance 64 CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect is an imaging artifact rather than a direct physical injury hazard, and no injuries are reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 108 units of the Brilliance 64 Computed Tomography X-ray system. These devices are intended to produce cross-sectional images of the body. The recall covers units distributed nationwide in the United States and in numerous countries worldwide.
The firm discovered that the affected systems produce Ring/Dot artifacts due to an X-ray measurement error. This defect affects the accuracy of the imaging produced by the devices.
The recall includes specific model and serial numbers listed in the official FDA notice. Consumers and healthcare facilities should contact Philips Medical Systems for further instructions on how to address this issue.
The recalled product
- Product
- Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 108
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: 2
- 9030
- 9047
- 9050
- 9152
- 9168
- 9234
- 9250
- 9542
- 9552
- 9627
- 9664
- 9690
- 9801
- 9915
- 9996
- 9999
- 10009
- 10066
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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