Devices

Device Recall Fujinon/Fujifilm

  • Modèle / numéro de série
    Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
  • Description du dispositif
    Fujinon/Fujifilm Ultrasonic Endoscope || Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
  • Manufacturer
    Fujinon Inc
  • 1 Event

Fabricant

Fujinon Inc
  • Adresse du fabricant
    Fujinon Inc, 10 Highpoint Dr, Wayne NJ 07470
  • Société-mère du fabricant (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA