Device Recall Eclipse TPS

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers all starting with H48 (model number): 6509, 6974, 6616, 6688, 6806, 6568, 6530, 6839, 6740, 7178, 6700, 6694, 6505, 6924, 6979, 6715, 6556, 6757, 6820, 6545, 6564, 7027, 6783, 6553, 6760, 6904, 6907, 7037, 6639, 7088, 6702, 6659, 6940, 6802, 6856, 6944, 6841, 6870, 6874, 6928, 6913, 6614, 7009, 6951, 6493, 6758, 7030, 6453, 6704, 6555, 6691, 6914, 6739, 6846, 6685, 6473, 7015, 6875, 6566, 6599, 6818, 7020, 6799, 6804, 6699, 7075, 6901, 6827, 6833, 6681, 6724, 6499, 6698, 6722, 7018, 6782, 6893, 6522, 6937, 6708, 6560, 6977, 6978, 6803, 6961, 6503, 6814, 7029, 6707, 6686
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed throughout the USA (in LA, IN, GA, MD, IL, AR, CA, MA, FL, AZ, SC, MO, CO, AL, OK, WA, MI, IN, NY, TX, MS, NE, TN, VA, WI, OR, DC, and NC) and internationally (Japan, Columbia, Canada, India, Czech Republic, Turkey, Germany, Portugal, Venezuela, Australia, South Korea).
  • 제품 설명
    Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Varian Medical Systems Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • 제조사 모회사 (2017)
  • Source
    USFDA