AdvantageSim MD versions 7 — Class II medical device recall Z-0754-2013
Terminated recall by GE Healthcare, LLC, reported 2013-02-06, distributed in AL, CT, FL, IL, MA, MO, NJ, NY…. It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series cou
| Recall number | Z-0754-2013 |
|---|---|
| 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 | 2013-01-30 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2014-01-16 |
| Distributed | AL, CT, FL, IL, MA, MO, NJ, NY, PA, TX, VA, WA, WI |
| Countries outside the US | AT, BR, CH, CL, CN, DE, DK, EG, FR, GB, IN, JP, KR, MY, NG, SE, TR, TW, ZA |
| Quantity | 65 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00000000210003, 00000000210010, 00000000210027, 00000000410007, 00000000410014 |
| Serial numbers | 000000010001GS, 000000010003GS, 000000010004GS, 000000010005GS, 000000210001GS, 000000210003GS, 000000210004GS, 000000210005GS, 000000210006GS, 000000210007GS, 000000210008GS, 000000210009GS, 000000210010GS, 000000210011GS, 000000210012GS, 000000210013GS, 000000210014GS, 000000210015GS, 000000210016GS, 000000210017GS, 000000210018GS, 000000210019GS, 000000210020GS, 000000210021GS, 000000210022GS and 40 more |
| Model numbers | 5160092-2 |
Product
AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
Reason for recall
It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.
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-0754-2013. 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.