Recall Z-0853-2014 ยท IZI System, X-Ray, Angiographic
GE Healthcare, LLC
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 angiographi
| Date | Jan 28, 2014 (initiated Nov 15, 2013) |
| 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 |
| Root cause | Software design |
| Action | GE Healthcare sent an "Urgent Medical Device Correction" letter dated November 15. 2013. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology / Surgery Department and Radiologists / Cardiologists / Surgeons. The letter described the Safety Issue, Safety Instructions, Affected Product Details, and Product Correction. The letter stated that GE Healthcare will correct all affected systems at no cost. For questions call (In US 800-437-1171; for other countries contact your local GE Healthcare Service Representative). |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122457 | GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS GE Healthcare, Jan 2, 2013 |