GE Healthcare — Class II medical device recall Z-1511-2014
Terminated recall by GE Healthcare, LLC, reported 2014-05-07. GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values repo
| Recall number | Z-1511-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-04-07 |
| Classified | 2014-04-25 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2014-05-29 |
| Countries outside the US | AU, CA, CH, CL, ES, FR, GB, IT, JP, KR, KW, NZ, PA, PL, SA, SE |
| Model numbers | 5434384-2, 5434389-2 |
Product
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation.
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-1511-2014. 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.