GE Seno Advantage 1 — Class II medical device recall Z-0095-2013
Terminated recall by GE Healthcare, LLC, reported 2012-10-31, distributed nationwide. GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital
| Recall number | Z-0095-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-05-24 |
| Classified | 2012-10-19 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2013-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BR, CA, CN, DE, DZ, ES, FR, GB, GR, HU, IT, JP, KR, MX, MY, NL, NZ, PT, RU, SA, SG, TW |
| Quantity | 188 |
| UPC / GTIN / UDI-DI | 00000000410007, 00000000410014, 00000000410021, 00000000410038, 00000000410045, 00000000410052, 00000000410069, 00000000410076, 00000000410083, 00000000410090, 00000000410106, 00000000410113, 00000000410120, 00000000410137 |
| Serial numbers | 000000410001GS, 000000410002GS, 000000410003GS, 000000410004GS, 000000410005GS, 000000410006GS, 000000410007GS, 000000410008GS, 000000410009GS, 000000410010GS, 000000410011GS, 000000410012GS, 000000410013GS, 000000410014GS, 000000410015GS, 000000410016GS, 000000410017GS, 000000410018GS, 000000410019GS, 000000410020GS, 000000410021GS, 000000410022GS, 000000410023GS, 000000410024GS, 000000410025GS and 164 more |
Product
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.
Reason for recall
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
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-0095-2013. 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.