Class II — GE Healthcare
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products. |
| Product | GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures. Discovery IGS 740: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures. |
| Quantity | 24 ( 7 US, 17 OUS) |
| Distribution | Worldwide Distribution-Distributed in the states of CO, CT, MS, NJ, NY, OH, and WA, and the countries of BELGIUM, CANADA, CHINA, FRANCE, GERMANY, JAPAN, MEXICO, PERU, UNITED ARAB EMIRATES, and UNITED KINGDOM. |
| Initiated | 2014-12-10 |
| Classified | 2015-01-14 |
| Terminated | 2015-06-01 |
| Recall number | Z-0966-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare (Z-0966-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70073/
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