GE Healthcare Optima IGS 320 — Class II medical device recall Z-0414-2016
Terminated recall by GE Medical Systems, LLC, reported 2015-12-23, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displ
| Recall number | Z-0414-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2015-11-13 |
| Classified | 2015-12-12 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2016-09-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | BD, BR, CN, DE, DO, DZ, ES, ID, IN, IT, LB, MA, PL, RU, TH, TR, TT |
| Quantity | 45 |
Product
GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 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-0414-2016. 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.