GE Healthcare — Class II medical device recall Z-0125-2013
Terminated recall by GE Healthcare, LLC, reported 2012-10-31, distributed nationwide. GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 wo
| Recall number | Z-0125-2013 |
|---|---|
| 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 | 2012-10-24 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2012-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | BH, CA, IT, TW |
| Quantity | 12 |
| UPC / GTIN / UDI-DI | 00000000010009 |
Product
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 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.
Reason for recall
GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size.
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-0125-2013. 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.