GE Healthcare Innova 2100 IQ — Class II medical device recall Z-1318-2013
Terminated recall by GE Healthcare, LLC, reported 2013-05-22, distributed nationwide. While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable l
| Recall number | Z-1318-2013 |
|---|---|
| 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 | 2013-05-14 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2014-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, CL, CN, DO, EC, GT, JP, KR, MX, MY, PA, PE, PH, PY, VE |
| Quantity | 713 |
| UPC / GTIN / UDI-DI | 00000000000024 |
| Serial numbers | 00000000000024, 00000000000029, 00000000000030, 00000000000032, 00000000000118, 00000000000119, 00000000000125, 00000000000128, 00000000000138, 00000000000143, 00000000000145, 00000000000151, 000000000SN155, 000000007C2008, 00000007C20001, 00000007C20002, 00000007C20003, 00000007C20004, 00000007C20005, 00000007C20007, 00000007C20012, 00000007C20013, 00000007C20014, 00000007C20016, 00000007C20020 and 475 more |
Product
GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.
Reason for recall
While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss.
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-1318-2013. 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.