Reported Sep 25, 2013 · Terminated
GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8,…
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 Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. 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
- Seno Advantage
- Workstations with RIS CCOW integrationPatient mismatch while receiving images - FMI 12187 Serial #
179 of 179 codes
00000179275GE300000136608GE700000136609GE500000123803GE900000206492GE100000179274GE600000179273GE800000179272GE000000177331GE600000128528GE700000132314GE600000106422GE900000188371GE900000179281GE100000179282GE900000106426GE000000106427GE800000250274GE800000142837GE400000142836GE6000000010001GS00000114907GE900000158810GE200000084251GE800000112122GE700000123807GE0000000310001GS000000010008GS000000010007GS00000106420GE300000114906GE100000250277GE100000165231GE200000136610GE300000114088GE800000114089GE600000112926GE100000206490GE500000154938GE500000190211HP300000174027GE300000174026GE500000190278HP2000000010004GS00000164500GE100000158809GE400000158410GE100000165228GE800000165229GE600000123804GE700000166277GE400000114091GE200000106425GE200000106424GE500000179280GE300000200442GE200000250278GE900000126082GE700000206491GE300000164502GE7
- Amount recalled
- 179
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety.
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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