Device Recall MHITM2000/ VERO (TM)

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers #s 201902 and 203901
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea.
  • 제품 설명
    MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. || MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment 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