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
    74651
  • Event Risk Class
    Class 2
  • Event Number
    Z-2303-2016
  • Event Initiated Date
    2016-01-30
  • Event Date Posted
    2016-07-29
  • 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=148106
  • 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
    A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
  • Action
    The recalling firm, Merge, issued an "URGENT: MEDICAL DEVICE RECALL" letter dated 1/27/2016 via e-mail on 1/30/2016 or via certified mail if they did not have an e-mail address for the customers. The letter described the product, problem and actions to be taken. The customers were instructed to not discontinue use of Merge PACS; to open prior comparison studies in the secondary viewer to check if there were annotations and read the report or visit note pertaining to that study to see if there are noted findings that were not otherwise apparent; to receive an upgrade call Merge Customer Service at (877) 741-5369 or send an email to support@merge.com to schedule the upgrade (Reference this call #2016-010); complete the online form: http://www.merge.com/Landing-Pages/Customer-Upgrade-Decline-Form.aspx no later than 2/22/2016; If you decide to decline the maintenance release, complete the attached Customer Decline Response form and return to Merge Healthcare via recall@merge.com, and ensure all users of the product are provided with this notification. If you have further distributed this product, identify your customers and notify them at once of this product recall. If you have any additional questions, call Merge Customer Service at (877) 741-5369 or support@merge.com.

Device

Device Recall Merge PACS
  • Model / Serial
    Versions: V6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6.0, 6.6.1, 6.6.1.1, 6.6.2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Jordan, New Zealand, and the United Kingdom.
  • Product Description
    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. || Merge PACS 6.0 is software 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.