Device Recall CIVCO SBRT System, REF MTSBRT001L

  • 모델명 / 제조번호(시리얼번호)
    M105110, M108810, M109210, M110470, M110500, M110510, M115630, M128700, M128710, M128720, M137600, M137610, M148780, M148790, M148800, M177910, M177920, M177930, M177940, M177950, M177960, M196700, M196710, M196720, M200120, M200130, M200140, M226740, M226750, M226780, M228640, M230110, M239340, M239350, M245100 and M258280
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA ( nationwide) including the state of PA. and countries of: Canada, China, England, Israel, Italy, Japan, Korea, The Netherlands, Russia, Spain, Sweden, Switzerland and Turkey.
  • 제품 설명
    CIVCO SBRT System, REF MTSBRT001L, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa || Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic and other medical procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Civco Medical Instruments Inc, 102 1st St S, Kalona IA 52247-9589
  • 제조사 모회사 (2017)
  • Source
    USFDA