The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film im...
FDA Recall #Z-0975-2017 — Class II — December 19, 2016
Product Description
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
Reason for Recall
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.
Recalling Firm
GE OEC Medical Systems, Inc — Salt Lake City, UT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
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
Code Information
Manufactured between 1/1/16 to 11/1/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated