FDA Device recall Z-1984-2015
GE Healthcare Innova IGS 630
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of GE Healthcare Innova IGS 630 by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (I….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1984-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-29 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Reason
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
Identifiers
| code_info | Serial Number System ID 0000012CC20012 YV1950 00000641154BU0 YV1915 646036BU4 412647IR1 00000649367B…Serial Number System ID 0000012CC20012 YV1950 00000641154BU0 YV1915 646036BU4 412647IR1 00000649367BU0 HCAALL630 00000656468BU6 5973XR0014 00000656469BU4 5973XR0013 657273BU9 936539CL5 Not Available 082416040067 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1984-2015%22
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