Device Recall Volcano brand Intravascular Ultrasound

  • Model / Serial
    All units of these models. Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. || Medical device for use in imaging of histology.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • Manufacturer Parent Company (2017)
  • Source
    USFDA