Z-0973-2017 Class II Terminated
FDA device recall Z-0973-2017 was initiated by GE OEC Medical Systems, Inc on December 19, 2016 and is designated Class II. 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 fail… The recall status is terminated (terminated August 22, 2017).
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2017
- Initiation Date
- December 19, 2016
- Termination Date
- August 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
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.
Distribution Pattern
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