Device Recall Diagnostic Ultrasound Unit

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 11743701 to 11743705  11837701 to 11837705  11906701 to 11906705  12006701 to 12006710  12124701 to 12124710  12315701 to 12315705  12427801 to 12427805
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution --- including states of OH, FL, CA, TX, DE, VA, NY, MO, KS, NJ, MD and ID.
  • 제품 설명
    EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
  • 제조사 모회사 (2017)
  • Source
    USFDA