Events

Recall of Merge Cardio 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
    77124
  • Event Risk Class
    Class 2
  • Event Number
    Z-2123-2017
  • Event Initiated Date
    2016-04-13
  • Event Date Posted
    2017-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154998
  • 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
    Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's mrn, resulting in the wrong fetal measurements getting referenced.
  • Action
    The recalling firm issued a "Medical Device Correction" letter dated 4/13/2016 via e-mail. The letter identified the affected product, issue involved, potential harm, a work around, as well as the actions to be performed by both the customer and firm. Merge Technical Support will contact customers to discuss the fix. Customers are to ensure that all users are provided the notice. If the affected product was further distributed, those customers should be identified and notified of the issue. A copy of the notice may be provided to those customers. If there are additional questions, customers can e-mail recall@merge.com.

Device

Merge Cardio software
  • Model / Serial
    Versions 10.0, 10.0.1, 10.1, 10.1.1,10.1.1.1, and 10.1.2.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.
  • Product Description
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. || Intended to be used to acquire, store, print, transfer, and archive clinical information.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.