Device Recall FastPlan Versions 5.5 and 5.5.1

  • Modèle / numéro de série
    All codes start with HZ3: 0001, 0021, 0032, 0033, 0044, 0403, 0404, 0407, 0422, 0426, 0681, 0684, 0698, 0703, 0727, 2035, 2036, 2037, 2039, 2040, 2126, 3020, 3021, 3022, 3026, 9016, 9018, 9066, 9071, 9165, 0054, 0058, 0061, 0077, 0108, 0110, 0111, 0112, 0131, 0139, 0144, 0154, 0167, 0171, 0178, 0182, 0190, 0207, 0208, 0224, 0230, 0251, 0258, 0265, 0273, 0280, 0283, 0293, 0294, 0312, 0330, 0342, 0349, 0368, 0398, 0460, 0461, 0462, 0485, 0495, 0500, 0507, 0508, 0509, 0510, 0511, 0513, 0520, 0531, 0537, 0540, 0556, 0557, 0571, 0572, 0573, 0588, 0594, 0604, 0612, 0617, 0620, 0624, 0630, 0640, 0646, 0649, 0656, 0670, 0675, 0730, 0731, 0737, 0740, 0743, 0762, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2012, 2013, 2014, 2016, 2017, 2018, 2018, 2020, 2021, 2022, 2024, 2025, 2026, 2027, 2028, 2029, 2032, 2033, 2034, 2042, 2044, 2045, 2046, 2047, 2048, 2049, 2050, 2051, 2052, 2053, 2054, 2055, 2056, 2058, 2059, 2060, 2061, 2062, 2063, 2064, 2065, 2067, 2069, 2071, 2072, 2073, 2074, 2075, 2076, 2077, 2084, 2086, 2108, 2125, 3030, 3031, 3039, 3041, 3042, 3044, 3046, 3047, 3049, 3050, 3053, 3055, 3059, 3062, 3064, 5070, 6101, 6102, 6302, 6303, 7002, 7003, 7005, 7007, 7010, 7011, 7015, 7027, 7101, 8006, 8062, 9002, 9004, 9007, 9010
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution - USA nationwide and the countries of Australia, Brazil, Canada, Chile, Colombia, Georgia, Germany, Hong Kong, India, Ireland, Japan, Macau, Malaysia, Russia, Singapore, Spain, Sri Lanka, and Taiwan
  • Description du dispositif
    Varian Medical Systems FastPlan software, Versions 5.5 and 5.5.1, Model Number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA || Treatment Planning System is intended as aid in quickly and precisely planning the radiation treatment of small cranial lesions such as an asteriovenous malformations, pituitar tumors, pincalomas, acoustic neuromas and malignant neoplasms.
  • 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