Events

Recall of Device Recall Merge OfficePACS3.xDat

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
    74510
  • Event Risk Class
    Class 2
  • Event Number
    Z-2159-2016
  • Event Initiated Date
    2016-01-31
  • Event Date Posted
    2016-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147805
  • 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
    Potential data loss occurs as a result of product archiving not working properly.
  • Action
    The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/31/2016 explaining the reason for recall and instructing the customer to provide a copy of the notification to all users.

Device

Device Recall Merge OfficePACS3.xDat
  • Model / Serial
    Version 3.4
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign distribution.
  • Product Description
    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.