FDA Device recall Z-2253-2013
GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IG….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2253-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-19 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use 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
GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting during procedure. The boot issue may occur when a large amount of patient data remains in the browser and is not deleted. The inability to boot the system ma
Identifiers
| code_info | Mfg Lot or Serial # 00000611882BU2 00000612803BU7 00000613979BU4 00000620447BU3 |
|---|
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-2253-2013%22
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