FDAFDA · Food and drugs·Recall number Z-0973-2017
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.
Published January 18, 2017 · Recall initiated: December 19, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE OEC Medical Systems, Inc
- Distributor
- 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
- Lot
- Manufactured between 1/1/16 to 11/1/16
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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