Device Recall Shimadzu FDR Visionary Suite

  • Modèle / numéro de série
    Serial No. 0162M4501 thru 0562M45103, 3ZC5C2A0C002 thru 3ZC5C1734001, D362M42902 thru 0562M41101, 41E733E69003, MP95A8F5A001 thru MP95A9F6B001
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide distribution to AK, AR, AZ, CA, CT, FL, IL, IN, KS, LA, MI, MO, NE, NJ, NM, NV, NY,OH, OK, PA, RI, SC, TN, TX, WA, WI, and Hawaii Foreign: Canada and Japan
  • Description du dispositif
    SHIMADZU FDR Visionary || Catalog Number: FDR Visionary Suite || Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Shimadzu Medical Systems Usa Com, 20101 S Vermont Ave, Torrance CA 90502-1328
  • Société-mère du fabricant (2017)
  • Source
    USFDA