Device Recall GE Healthcare Surgery OEC 9800

  • Model / Serial
    Manufactured between 1/1/16 to 11/1/16
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 N Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Manufacturer Parent Company (2017)
  • Source
    USFDA