Device Recall Fujinon/Fujifilm

  • Model / Serial
    Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Fujinon Inc, 10 Highpoint Dr, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
  • Source
    USFDA