Device Recall Olympus ImageManager Software

  • Model / Serial
    Versions 6.0 through 6.4.1 (excluding version 6.3.8)
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Medical facilities (end users) nationwide and Puerto Rico, plus 5 foreign accounts located in Canada, Mexico, Ecuador and Chile.
  • Product Description
    Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8) || Common name: Medical image storage device. Class I, 510 (k) exempt. (NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking. It is a condition of the software malfunction that the observed image crosslink results from the collision of data files from two separate ImageManager computers.)
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Olympus America Inc., Two Corporate Center Drive, Melville NY 11747
  • Source
    USFDA