Philips Brilliance iCT Systems Recalled for Potential Image Artifacts
Philips Medical Systems is recalling Brilliance iCT and iCT SP systems because an artifact resembling a thrombus may appear on images.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential diagnostic error (artifact resembling thrombus) which poses a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 506 units of the Brilliance iCT and Brilliance iCT SP 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 potential defect where an artifact that resembles a thrombus may appear on the image.
The affected units were distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international countries. The recall covers specific model numbers 728306 and 728311 with a wide range of serial numbers listed in the official notice.
Healthcare facilities and consumers should contact Philips Medical Systems for further instructions on how to address this issue. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Brilliance iCT and Brilliance iCT SP 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. May include signal analysis and display equipment, patient and equipment…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 506
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 # 728306 100016
- 100018
- 100019
- 100020
- 100021
- 100022
- 100023
- 100024
- 100025
- 100028
- 100031
- 100032
- 100037
- 100038
- 100039
- 100040
- 100042
- 100043
- 100044
- 100045
Distribution
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