Device Recall Hi Vision ultrasound diagnostic scanners

  • Model / Serial
    The following Serial Numbers for this device were subject to recall/software correction: 17094308, 17094309, 17150307, 17350302, 17094305, 17869402, 18435403, 18435404, 17492302, and 17204305.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled device system units were distributed to customers located in the following states within the U.S ony.: AR, CA, and TX.
  • Product Description
    EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A.
  • Manufacturer
  • 1 Event

Manufacturer

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