Device Recall GE OEC 9900 Elite Fluoroscopic xray system

  • Model / Serial
    Serial numbers: E2-0155, E2-0156, E2-0157, E2-0164, E2-0167, E2-0168, E2-0170 thru E2-0234, E2-0235-C, E2-0236 thru E2-0257, E2-0259, E2-7048-MH, E2-7050-MH, E2-7051-MH, E2-7058-MH, E2-7059-MH, E2-7060-MH, E2-7061-MH, E2-7062-MH, E2-7064-MH, E2-7065-MH, E2-7066-MH, E2-7067-MH, E2-7068-MH, E2-7069-CMH, E2-7070-MH, E2-7071-MH, E2-7072-MH, E2-7073-MH, E2-7074-MH, E2-7076-MH, E2-7077-CMH, E9-0037, E9-0085, E9-0088, E9-0089-G, E9-0090, E9-0093, E9-0094, E9-0095, E9-0098 thru E9-0103, E9-0108 thru E9-0153, E9-0155, E9-0156, E9-0157, E9-0158, E9-0159, E9-0162, E9-0163, E9-0164, E9-0165, E9-0170, E9-0171, E9-0172, E9-0173, E9-0178, E9-0183, ES-0041-G, ES-0069, ES-0071, ES-0072, ES-0078, ES-0084-G, ES-0086-G, ES-0087, ES-0088, ES-0089, ES-0090, ES-0092-CH, ES-0096, ES-0097, ES-0098, ES-0099-CH, ES-0101-CH, ES-0103, ES-0104, ES-0106 thru ES-0130, ES-0131-H, ES-0132 thru ES-0154, ES-0155-H, ES-0156, ES-0157, ES-0158, ES-0159, ES-0160, ES-0162-G thru ES-0167-G, ES-0169-CH, ES-0170, ES-0171, ES-0172, ES-0173, ES-0175, ES-0176, ES-0177, ES-0178, ES-0184, ES-7018-MH, ES-7026-CMH thru ES-7031-CMH, ES-7032-MH, ES-7033-CMH, ES-7034-CMH, ES-7035-CMH, ES-7036-CMH.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA including states of FL, GA, PA. CO, MD, VA and WA. and countries of Australia, Austria, Belgium, Brazil, Canada, Colombia, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal, Switzerland, Taiwan, and the UK.
  • Product Description
    GE OEC 9900 Elite Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA