Events

Recall of Device Recall OLS Symphony. DFC1024 & DFC512 DIGITAL IMAGING SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merge Healthcare, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75914
  • Event Risk Class
    Class 2
  • Event Number
    Z-1246-2017
  • Event Initiated Date
    2016-03-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151691
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image management, ophthalmic - Product Code NFJ
  • Reason
    Eye station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an medical record number (mrn).
  • Action
    The recalling firm issued a letter dated 3/28/2016 via e-mail. If no email address was available, the letters were issued via certified mail. A follow-up letter dated 7/11/2016 was also issued.

Device

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.

Manufacturer

Merge Healthcare, Inc.