Devices

Device Recall OLS Symphony. DFC1024 & DFC512 DIGITAL IMAGING SYSTEM

  • Model / Serial
    Merge ESIU: Versions 1.0, 1.1.1, 1.1.2, and 1.1.3; Merge Eye Station: All versions; Merge Eye Care PACS: Versions 4.1, 4.2, 4.3, 5.0, and 5.1
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was nationwide to medical facilities. There was also government and foreign distribution, including Canada.
  • Product Description
    Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event

Manufacturer

Merge Healthcare, Inc.