Reported Oct 31, 2012 · Terminated
GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage…
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?
- GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.
- Lot codes and dates
- Mfg Lot or Serial #FMI# 12129_SA1.x Mfg Lot or Serial #
145 of 145 codes
SA2000000410032GS000000410033GS000000410027GS000000410047GS000000410041GS000000410051GS000000410087GS000000410065GS000000410031GS000000410035GS000000410136GS000000410064GS000000410037GS000000410030GS000000410049GS000000410028GS000000410113GS000000410069GS000000410052GS000000410056GS000000410043GS000000410044GS000000410048GS000000410038GS000000410042GS000000410101GS000000410036GS000000410039GS000000410073GS000000410054GS000000410134GS000000410062GS000000410112GS000000410045GS000000410063GS000000410060GS000000410034GS000000410072GS000000410057GS000000410061GS000000410058GS000000410050GS000000410071GS000000410059GS000000410055GS000000410070GS000000410053GS000000410029GS000000410067GS000000410068GS000000410066GS000000410133GS000000410011GS000000410010GS000000410009GS000000410007GS000000410006GS000000410008GS000000410096GS
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
- Mfg Lot or Serial #
- Amount recalled
- 188
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. The measurement values provided by the Seno Advantage Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiv
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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