Devices

ECLOS Computed Tomography XRay System

  • Modèle / numéro de série
    The recalled ECLOS system units are identified with the following Code Numbers: E1014, E5003 through E5005
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution, including Puerto Rico (PR).
  • Description du dispositif
    Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less.
  • Manufacturer
    Hitachi Medical Systems America Inc
  • 1 Event

Fabricant

Hitachi Medical Systems America Inc
  • Adresse du fabricant
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087
  • Société-mère du fabricant (2017)
    Hitachi Ltd
  • Source
    USFDA