Philips Recalls Brilliance 16-Slice CT Systems Due to X-ray Measurement Error
Philips Medical Systems is recalling 323 Brilliance 16-Slice CT systems worldwide due to X-ray measurement errors causing 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, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is a technical measurement error affecting image quality, which fits the criteria for a moderate severity recall without reported adverse health consequences.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 323 units of the Brilliance 16-Slice (Air) Computed Tomography X-ray systems. 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 X-ray measurement error. This defect may affect the accuracy of the images produced by the equipment. The recall includes specific model and serial numbers listed in the official FDA documentation.
Healthcare facilities and consumers with these specific units should contact Philips Medical Systems for instructions on how to resolve the issue. No specific consumer action is detailed in the source text beyond the identification of the affected units.
The recalled product
- Product
- Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 323
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. 728246
- S/N: 3007
- 3016
- 3047
- 3095
- 3127
- 3331
- 3359
- 3410
- 3478
- 3482
- 3500
- 3679
- 3702
- 4042
- 5049
- 5067
- 5068
- 5072
- 5073
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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