Reported Jan 23, 2013 · Terminated
Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity…
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Brilliance 64 and Ingenuity CT Computed
- Tomography X-Ray Scanning Systems
Brilliance 64 - Model #728231and Ingenuity CT - Model # 728326
- Distributed ByPhilips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT 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 different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories
- Lot codes and dates
- Brilliance CT X-RAY System - Model/System Code #728231, Serial Number distributed in the U.S
- was9654. Ingenuity CT X-Ray System - Model/System Code #728326 - Serial Numbers distributed in the U.S
- were
300018and 300003. The remaining Serial
- Numbers distributed overseas were
91003951309515795504
- and Serial Numbers
300010and 300030
- Amount recalled
- A total of nine (9) units were distributed (3 units in the U.S & 6 units overseas)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Software anomalies. Philips Medical Systems recalled their Brilliance 64 running software v4.0.0xx516 and their Ingenuity CT running software v4.0.0xx518 due to software issues detected in these CT scanning systems. If these issues were to re-occur they could pose the risk of injury to patients undergoing scans; device users; or device service personnel.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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