Device Recall CyberKnife Robotic Radiosurgery Systems

  • Modèle / numéro de série
    models: G3, G4, VSI. Serial numbers: C0023 C0030 C0045 C0046 C0047 C0006 C0012 C0040 C0048 C0049 C0013 C0011 C0052 C0055 C0022 C0053 C0042 C0057 C0017 C0059 C0056 C0060 C0062 C0061 C0067 C0068 C0070 C0041 C0063 C0065 C0074 C0071 C0079 C0078 C0080 C0064 C0090 C0024 C0087 C0091 C0095 C0094 C0092 C0093 C0097 C0098 C0099 C0100 C0101 C0102 C0103 C0106 C0089 C0108 C0107 C0105 C0112 C0114 C0118 C0119 C0113 C0123 C0126 C0124 C0121 C0132 C0130 C0131 C0125 C0133 C0135 C0117 C0134 C0038 C0136 C0137 C0127 C0143 C0144 C0014 C0138 C0146 C0140 C0145 C0150 C0033 C0151 C0152 C0147 C0149 C0148 C0158 C0155 C0159 C0007 C0163 C0157 C0165 C0008 C0162 C0085 C0161 C0086 C0073 C0115 C0076 C0153 C0077 C0111 C0066 C0027 C0075 C0084 C0096 C0154.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including CA. MN, OK. FL. MO, TN, KS, TX, AZ, MS, IA, MA. NC, NY. IN, NJ, VA. LA, WA, WI, PA. CT, G,. MT, MD, LA., WV, OH, and DC. Foreign distribution to Taiwan, Japan, Korea, Turkey. Malaysia, Vietnam, Greece, China, Spain, France, Italy, Pakistan, and Georgia,
  • Description du dispositif
    CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. || Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when || radiation treatment is indicated.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Accuray Incorporated, 1310 Chesapeake Ter, Sunnyvale CA 94089-1100
  • Société-mère du fabricant (2017)
  • Source
    USFDA