Philips Brilliance iCT Computed Tomography Systems Recalled for Image Artifacts
Philips is recalling seven Brilliance iCT and iCT SP CT scanners because patient images exhibited ring 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, and the source text describes a technical defect (ring artifacts) without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling seven units of the Brilliance iCT and Brilliance iCT SP Computed Tomography X-Ray Systems. These whole-body imaging devices are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
The recall was initiated because patient images exhibited ring artifacts. The affected units were distributed worldwide, including nationwide in the United States (specifically in Florida, Indiana, New York, Oregon, and Pennsylvania) and internationally to Australia and Israel.
Healthcare facilities that possess these specific serial numbers should contact Philips Medical Systems for further instructions on the recall. The affected serial numbers are 100018, 100040, 100411, 100503, and 100506 for the Brilliance iCT, and 200047 and 200121 for the Brilliance iCT SP.
The recalled product
- Product
- Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 7
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 (8)
- Brilliance iCT: 728306
- Serial #'s: 100018
- 100040
- 100411
- 100503
- 100506 Brilliance iCT SP: 728311
- Serial #'s: 200047
- 200121
Distribution
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