Innova IGS 630 — Class II medical device recall Z-1199-2019
Ongoing recall by GE Healthcare, LLC, reported 2019-04-24, distributed nationwide. There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30c
| Recall number | Z-1199-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-03-15 |
| Classified | 2019-04-18 |
| Reported by FDA | 2019-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CN, CO, DZ, FR, HU, IT, JP, KR, KW, PK, PL, RU, SA, TR, VN, ZA |
| Quantity | 1 devices |
| Serial numbers | B3-16-015 |
| Model numbers | 5503558 |
Product
Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Reason for recall
There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.
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-1199-2019. 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.