Events

Recall of Merge Unity 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
    77811
  • Event Risk Class
    Class 2
  • Event Number
    Z-3105-2017
  • Event Initiated Date
    2017-08-14
  • Event Date Posted
    2017-08-18
  • 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=157956
  • 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 identifying the patient as having atypical hyperplasia, resulting in an incorrect gail risk calculation.
  • Action
    MERGE sent a Medical Device Recall letter dated August 11, 2017, to all affected customers. Customers were advised to discontinue using the affected product and to reply using the enclosed form. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 262-912-3514.

Device

Merge Unity software
  • Model / Serial
    Software versions 10.0, 10.0.1, 10.0.2, 10.0.3, 10.0.4, 10.0.5, 11.0, 11.0.1, 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1, 11.1.1.1, 11.1.1 Patch 2, 11.1.1 Patch 3, 11.1.2, 11.1.2 Patch 1, 11.1.2 Patch 2, 11.1.2 Patch 3, and 11.1.2 Patch 4.  Only customers with one of the above listed software versions AND a license for Mammo Tracking are impacted by this recall.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. || Merge Unity 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.