Device Recall MHITM2000/VERO

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 201901, 201902, 201903, 201904, 201905, 202901, 202902, 202903, 202904, 202905, 202906, 203901, 203902, 203903, 203904, 203905, 203906, 203918, 203919, 203921, 203922, 203924, 203925, 203927 and 203929.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium.
  • 제품 설명
    MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) || Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU, HIROSHIMA Japan
  • 제조사 모회사 (2017)
  • Source
    USFDA