Device Recall CXR4CT (including Sceptre P3 PET/CT)

  • 모델명 / 제조번호(시리얼번호)
    CXR46201-46214 PC46002-46011
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The 16 devices were distributed to 11 states: Texas, Florida, Louisiana, Illinois, Connecticut, Ohio, Massachusetts, Wisconsin, Idaho, California, New Jersey
  • 제품 설명
    Hitachi Emission Computed Tomography System || Hitachi CX-4 CT (including SceptreP3 PET-CT)
  • Manufacturer
  • 1 Event

제조사

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