Reported Feb 6, 2013 · Terminated
AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
GE Healthcare, LLC
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: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
AdvantageSim MD versions 7.4 through 7.6Model 5160092-2 Version 7.45160092-3 Version 7.55160092-4 version 7.6
- Lot codes and dates
- Mfg Lot or Serial #
65 of 65 codes
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
- Mfg Lot or Serial #
- Amount recalled
- 65
Where it was sold
Why it was recalled
It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.
This product could cause temporary or reversible health problems — stop using it.
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