Device Recall Volcano s5/s5i imaging system software version 3.2

  • Model / Serial
    Software version 3.2, Part Numbers 435-0602.01 to 05,
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, and the countries of France, Germany, Japan, and the UK.
  • Product Description
    Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA.
  • Manufacturer
  • 1 Event

Manufacturer

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