Device Recall CXR4CT (including Sceptre P3 PET/CT)

  • Model / Serial
    CXR46201-46214 PC46002-46011
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The 16 devices were distributed to 11 states: Texas, Florida, Louisiana, Illinois, Connecticut, Ohio, Massachusetts, Wisconsin, Idaho, California, New Jersey
  • Product Description
    Hitachi Emission Computed Tomography System || Hitachi CX-4 CT (including SceptreP3 PET-CT)
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
  • Manufacturer Parent Company (2017)
  • Source
    USFDA