Reported Mar 20, 2013 · Terminated
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body…
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 Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body 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. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
- Lot codes and dates
- Brilliance 64728231 &
- Ingenuity CT
728326728323. System Code # 728231Serial #: 965491003951309515795504 System Code # 728326Serial #: 32000300003300004300005300010300011300012300014300015300018300027300041300053300059300066300070300071300073300074300078300079300080300082300084300086300091300095300101300102300112300127300128300129300131300132310064 System Code # 728323Serial #: 320033
- Amount recalled
- 42 Units
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
This field change order is being released to update software and customer release notes to the affected installed base.
This product could cause temporary or reversible health problems — stop using it.
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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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