Device Recall Brachytherapy System, Remote Afterloader

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 212, 215, 222, 224, 239, 246, 271, 274, 281, 293, 308, 322, 333, 343, 346, 388, 394, 401, 403, 406, 411, 431, 436, 437, 438, 441, 444, 446, 450, 456, 462, 500, 501, 505, 509, 510, 511, 512, 513, 514, 515, 516, 518, 519, 521, 522, 527, 530, 532, 535, 536, 538, 539, 540, 541, 542, 544, 545, 546, 548, 551. Part Number: AL20020000 (VariSource iX Afterloader
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide)
  • 제품 설명
    VariSource iX, Software Version 1.1, Part Number AL20020000 VariSource iX Afterloader. || The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electra/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 20 channels for treatment.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Varian Medical Systems, Inc., 700 Harris St Ste 109, Charlottesville VA 22903-4584
  • 제조사 모회사 (2017)
  • Source
    USFDA