Innova 4100IQ Indicated for use in generating fluoroscopic images of… — Class II medical device recall Z-0453-2015
Terminated recall by GE Healthcare, LLC, reported 2014-12-24, distributed in CA, CO, FL, MO, PA. Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry mot
| Recall number | Z-0453-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-09-04 |
| Classified | 2014-12-12 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2015-01-21 |
| Distributed | CA, CO, FL, MO, PA |
| Countries outside the US | BE, CN, CO, FR, GR, MX, RU |
Product
Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
Reason for recall
Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.
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-0453-2015. 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.