Class II — GE Healthcare, LLC
| 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 | GE Healthcare has recently become aware of a potential safety issue with respect to IGS 630 Imaging Systems. While performing fluoroscopy on a biplane fluoroscopy unit, there is a potential for loss of the x-ray imaging function when the user changes the size of the lateral FOV (Field of View) and releases the biplane footswitch pedal simultaneously. This could lead to a system lock up requiring |
| Product | GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: 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 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… |
| Quantity | 28 (12 US, 16 OUS). |
| Distribution | Worldwide Distribution - US Nationwide in the states of CA, CO, FL, NV, NJ, PA, TX and the countries of CZECH REPUBLIC, FRANCE, JAPAN, REPUBLIC OF KOREA, SAUDI ARABIA, and TURKEY. |
| Initiated | 2013-11-15 |
| Classified | 2014-01-28 |
| Terminated | 2014-03-28 |
| Recall number | Z-0853-2014 |
| 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, LLC (Z-0853-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67325/
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