Device Recall Diagnostic Ultrasound Unit

  • Modèle / numéro de série
    Serial Numbers: 11743701 to 11743705  11837701 to 11837705  11906701 to 11906705  12006701 to 12006710  12124701 to 12124710  12315701 to 12315705  12427801 to 12427805
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution --- including states of OH, FL, CA, TX, DE, VA, NY, MO, KS, NJ, MD and ID.
  • Description du dispositif
    EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087-2371
  • Société-mère du fabricant (2017)
  • Source
    USFDA