Events

Recall of Device Recall Merge FlexConnect software

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
    75334
  • Event Risk Class
    Class 2
  • Event Number
    Z-0664-2017
  • Event Initiated Date
    2016-01-30
  • 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=150060
  • 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
    Medical device data system - Product Code OUG
  • Reason
    Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the lis software.
  • Action
    The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016. Nonresponders were issued a second letter dated 5/25/2016 via email on 5/26/2016.

Device

Device Recall Merge FlexConnect software
  • Model / Serial
    Version 1.0
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Merge FlexConnect software, a component of Merge LIS. || Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.