Philips Brilliance CT Systems Recalled for Dose Calculation Issue
Philips is recalling 23 Brilliance CT systems because the DoseRight feature may suggest higher radiation doses for large children than expected.
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 involves a risk-of-harm product (excessive radiation exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 23 units of the Brilliance iCT, Brilliance 64, and Brilliance Big Bore Computed Tomography (CT) X-Ray Systems. The recall involves specific model and serial numbers distributed in the United States and several international countries.
The recall is due to a software issue with the DoseRight feature, which suggests a tube current (mAs) based on patient size. When scanning large children, the system may suggest an mAs value that is higher than clinicians would typically expect. This could result in higher radiation exposure for pediatric patients.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue. The affected devices are identified by specific model and serial numbers listed in the recall documentation.
The recalled product
- Product
- Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 23
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)
- Brilliance iCT: Model Number 728311 and 728306
- Serial Number: 100103
- 100019
- 100023
- 100170
- 200047
- 200013 200005 and 100087. Brilliance 64: Model Number 728231 and 728326
- Seial Number: 4003
- 9745
- 9875
- 90135
- 90169
- 95414
- 300003
- 300004
- 300005 and 300010. Brilliance CT Big Bore
- Model Number: 728243
- Serial Number: 7006
- 7060
- 7154
Distribution
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