GE Healthcare — Class II medical device recall Z-2257-2013
Terminated recall by GE Healthcare, LLC, reported 2013-09-25, distributed nationwide. GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Ad
| Recall number | Z-2257-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-09-20 |
| Classified | 2013-09-19 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2016-07-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, DE, ES, FI, FR, GB, IQ, JP, LB, NO, PT, SE, TW |
| Quantity | 179 |
| UPC / GTIN / UDI-DI | 00000000610001, 00000003510001 |
| Serial numbers | 000000010001GS, 000000010002GS, 000000010003GS, 000000010004GS, 000000010005GS, 000000010006GS, 000000010007GS, 000000010008GS, 000000010011GS, 000000210002GS, 00000022062GE9, 000000310001GS, 000000310002GS, 000000310003GS, 00000050604AW8, 00000050605AW5, 00000050606AW3, 00000050607AW1, 000000510001GS, 00000054750AW5, 00000054849AW5, 000000610001GS, 000000610002GS, 000000610005GS, 000000610006GS and 153 more |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2257-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.