Events

Recall of Device Recall Merge PACS

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
    74776
  • Event Risk Class
    Class 2
  • Event Number
    Z-2363-2016
  • Event Initiated Date
    2016-02-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148421
  • 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
    When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the hologic imager (different image), the measurements are not the same.
  • Action
    The recalling firm's customer support notified customers via phone call beginning 2/5/2016 to inform them of the issue. Customers were informed that a software fix that corrects the issue was available. Customers were asked not to use the measurements on mammo images until upgraded. If customers want an upgrade, then someone would contact them to schedule the upgrade.

Device

Device Recall Merge PACS
  • Model / Serial
    Software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Australia.
  • Product Description
    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. || Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.