GE Healthcare Advantx — Class II medical device recall Z-0947-2013
Terminated recall by GE Healthcare, LLC, reported 2013-03-20, distributed nationwide. A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, I
| Recall number | Z-0947-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-01-21 |
| Classified | 2013-03-13 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2014-01-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BR, CA, CN, EG, ES, FR, GB, GR, HU, ID, IN, IT, JP, LB, MA, MT, NG, NI, NO, NZ, PL, PT, SA, TH, TR, TW, VE |
| Quantity | 297 |
| UPC / GTIN / UDI-DI | 00000000128124 |
| Model numbers | 2223039-2, 2236709, 2270677-2, 2353620 |
Product
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2.
Reason for recall
A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging 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-0947-2013. 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.