GE Healthcare — Class II medical device recall Z-2241-2013
Terminated recall by GE Healthcare, LLC, reported 2013-09-25, distributed in IL, MN, NJ, NY, VA. GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, inco
| Recall number | Z-2241-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-03-27 |
| Classified | 2013-09-18 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2014-11-21 |
| Distributed | IL, MN, NJ, NY, VA |
| Countries outside the US | AU, BE, BR, CA, CH, DE, DK, DZ, ES, FI, FR, GB, ID, IL, IN, IT, JP, KR, LV, NL, NO, PH, PL, RO, RU, SA, SE, SG, TH, TN, TR, VN, ZA |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00000000010047, 00000000010054 |
| Serial numbers | 000000010001GS, 000000010002GS, 000000010005GS, 000000010006GS, 000000010012GS, 000000010013GS, 000000010022GS, 000000010029GS, 000000010032GS, 000000010034GS, 000000010038GS, 000000010039GS, 000000010040GS, 000000010041GS, 000000010042GS, 000000010043GS, 000000010044GS, 000000010045GS, 000000010047GS, 000000010048GS, 000000010049GS, 000000010051GS, 000000010053GS, 000000010054GS, 00000206069HP7 and 293 more |
Product
GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
Reason for recall
GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.
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-2241-2013. 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.