GE Healthcare — Class II medical device recall Z-0934-2013
Terminated recall by GE Healthcare, LLC, reported 2013-03-20, distributed in FL, IL, IN, NC, NJ, OK, TX, WI. Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tu
| Recall number | Z-0934-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2011-02-04 |
| Classified | 2013-03-11 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2014-01-27 |
| Distributed | FL, IL, IN, NC, NJ, OK, TX, WI |
| Countries outside the US | BR, CN, CO, FI, FR, GB, ID, IN, IT, KR, LB, LT, NG, NO, RS, TN |
| Quantity | 48 |
| Serial numbers | 590867BU8, 592042BU6, 592043BU4, 592046BU7, 592047BU5, 592049BU1, 592050BU9, 592451BU9, 592452BU7, 592455BU0, 592456BU8, 592457BU6, 592458BU4, 592459BU2, 592460BU0, 592673BU8, 592674BU6, 592675BU3, 592676BU1, 592678BU7, 592680BU3, 592682BU9, 593048BU2, 593049BU0, 593051BU6 and 23 more |
Product
GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy.
Reason for recall
Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected.
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-0934-2013. 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.