Philips Brilliance iCT Computed Tomography System Software Defect Recall
Philips Medical Systems is recalling 16 Brilliance iCT Computed Tomography X-Ray Systems due to a software defect that may prevent scans from terminating at the intended location.
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 (medical device) where the defect may cause unintended radiation exposure, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips Medical Systems, Inc. is recalling 16 units of the Brilliance iCT Computed Tomography X-Ray System. The recall involves systems running software version 4.1 that were distributed in the United States.
The recall was initiated because a software defect was discovered that may result in the scanner not terminating the CT scan at the intended location. The Brilliance iCT/Brilliance iCT SP is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different…
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 16
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 (1)
- Software version 4.1.
Distribution
Distribution scope not specified by the agency.
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