GE Healthcare — Class II medical device recall Z-0021-2014
Terminated recall by GE Healthcare, LLC, reported 2013-10-23, distributed nationwide. GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Moni
| Recall number | Z-0021-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-08-16 |
| Classified | 2013-10-17 |
| Reported by FDA | 2013-10-23 |
| Terminated | 2014-05-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BO, BR, CA, CL, CN, CO, CZ, DE, DO, DZ, EC, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IN, IR, IT, JM, JO, JP, KR, KW, LB, LT, MA, MT, MX, MY, NG, NI, NL, NO, NZ, PA, PE, PH, PK, PL, PT, PY, RO, RS, RU, SA, SE, SK, TH, TN, TR, TT, TW, UA, VE |
| UPC / GTIN / UDI-DI | 00000000000611, 00000000000727, 00000000000741, 00000000000789, 00000000128124, 00000030190443, 00000034379448, 00082406010005, 00082406030003, 00082406040019, 00082406040026, 00082406070009, 00082406090007, 00082406090014, 00082406090021, 00082406100010, 00082406110002, 00082406120001, 00082406130017, 00082406140016, 00082406150008, 00082406160007, 00082406160038, 00082406190004, 00082406190011 and 15 more |
Product
GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.
Reason for recall
GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, 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-0021-2014. 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.