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GE Healthcare recalls GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generating fluoroscopic and rotational images of hum
Recalled July 8, 2015 · FDA recall Z-1983-2015 · GE Healthcare
Hazard
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery). · FDA Class II
Units
3
Sold at
Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.
Description
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
Product
GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Manufacturer(s)
GE Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →