GE Healthcare innova 3100 — Class II medical device recall Z-0113-2013
Terminated recall by GE Healthcare, LLC, reported 2012-10-31, distributed nationwide. It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova
| Recall number | Z-0113-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2011-12-20 |
| Classified | 2012-10-22 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2013-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 199 installed |
| Model numbers | 5892935G052G |
Product
GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
Reason for recall
It was discovered of a potential failure of the spectral filter mechanism inside the collimator of the innova 3100, innova 3100-IQ and innova 3131-IQ systems.
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-0113-2013. 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.