Device Recall Eclipse TPS

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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).
  • Description du dispositif
    Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Varian Medical Systems Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Société-mère du fabricant (2017)
  • Source
    USFDA