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GE OEC Medical Systems, Inc recalls The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient dur
Recalled January 18, 2017 · FDA recall Z-0975-2017 · GE OEC Medical Systems
Hazard
GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures. · FDA Class II
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Worldwide Distribution - US including U.S. States: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PUERTO RICO, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada, Mexico, and Costa Rica
Description
GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.
Product
The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretionOEC 9900 Elite. MDL Numbers: D148942, D155043
Manufacturer(s)
GE OEC Medical Systems, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →