GE Healthcare Innova IGS 540 — Class II medical device recall Z-1982-2015
Terminated recall by GE Healthcare, reported 2015-07-08, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantr
| Recall number | Z-1982-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2015-05-29 |
| Classified | 2015-07-02 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2015-10-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BE, BR, CA, CL, CN, DE, FR, GB, HK, HU, ID, IN, IT, JP, RU, VN |
| Quantity | 6 |
Product
GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
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-1982-2015. 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.