Events

Recall of Merge Unity

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
    76471
  • Event Risk Class
    Class 2
  • Event Number
    Z-1385-2017
  • Event Initiated Date
    2016-04-08
  • Event Date Posted
    2017-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153285
  • 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 processing, radiological - Product Code LLZ
  • Reason
    The software is not adding the correct tomo image.
  • Action
    Merge sent an Urgent Medical Device Recall dated July 11, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions send an email to recall@merge.com

Device

Merge Unity
  • Model / Serial
    Versions 11.0 and 11.0.1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, and TX.
  • Product Description
    DR Systems Unity PACS software, now known as Merge Unity PACS. || Product Usage: || Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.