Device Recall FastPlan Versions 5.5 and 5.5.1

  • Modelo / Serial
    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
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Varian Medical Systems Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA