GE Healthcare — Class II medical device recall Z-1142-2013
Terminated recall by GE Healthcare, LLC, reported 2013-04-24, distributed nationwide. As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantr
| Recall number | Z-1142-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2011-10-21 |
| Classified | 2013-04-18 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2014-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BH, CA, CZ, ES, FI, GB, HK, ID, IL, IT, LV, VN |
| Quantity | 48 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00000000000000 |
| Serial numbers | 00000000000000, 00000000026WV5, 00000000132WV1, 00000000249WV3, 00000000250WV1, 00000000251WV9, 00000000252WV7, 00000000253WV5, 00000000254WV3, 00000000255WV0, 00000000257WV6, 00000000263WV4, 00000000265WV9, 00000000267WV5, 00000000271WV7, 00000000274WV1, 00000000275WV8, 00000000280WV8, 00000000292WW3, 00000000297WV2, 00000000298WV0, 00000000301WV2, 00000000303WV8, 00000000305WV3, 00000000317WV8 and 23 more |
Product
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.
Reason for recall
As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the C-arm gantry pivot and the head section of the table, there is a risk of co
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-1142-2013. 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.