Philips Recalls Brilliance 64 and Ingenuity CT Scanners Due to Software Anomalies
Philips Medical Systems is recalling nine CT scanning systems due to software anomalies that could pose a risk of injury to patients and personnel if the issues recur.
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 source text explicitly states that the software issues could pose a risk of injury to patients and personnel, but does not report any actual injuries or illnesses, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling the Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems. The recall involves nine units in total, with three units distributed in the United States and six units distributed overseas in Australia, Belgium, China, Israel, and Sweden.
The recall is due to software anomalies detected in the Brilliance 64 (running software v4.0.0xx516) and Ingenuity CT (running software v4.0.0xx518). If these software issues were to re-occur, they could pose a risk of injury to patients undergoing scans, device users, or device service personnel.
The affected units are identified by specific model and serial numbers. For the Brilliance 64 (Model #728231), the U.S. serial number is 9654. For the Ingenuity CT (Model #728326), the U.S. serial numbers are 300018 and 300003. Overseas serial numbers include 91003, 95130, 95157, 95504, 300010, and 300030. Users should contact Philips Medical Systems for further instructions regarding the software issues.
The recalled product
- Product
- Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
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 (7)
- Brilliance CT X-RAY System - Model/System Code #728231
- and 300003. The remaining Serial Numbers distributed overseas were: 91003
- 95130
- 95157
- 95504
- and Serial Numbers: 300010
- and 300030 .
Distribution
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