GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System — Class II medical device recall Z-2253-2013
Terminated recall by GE Healthcare, LLC, reported 2013-09-25, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging
| Recall number | Z-2253-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-06-19 |
| Classified | 2013-09-18 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2013-10-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR, SG |
| Serial numbers | 00000611882BU2, 00000612803BU7, 00000613979BU4, 00000620447BU3 |
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 for recall
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
Machine access
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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.