FDA Device recall Z-1199-2019
Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovasc…
- FDA Device
- Class II
- ongoing
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovasc… by Ge Healthcare, citing 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 footsw….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1199-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-03-15 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | Model Number 5503558; System ID Number 0850060757; Serial Number B3-16-015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1199-2019%22
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