Events

Recall of Device Recall 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
    75027
  • Event Risk Class
    Class 2
  • Event Number
    Z-2709-2016
  • Event Initiated Date
    2016-02-09
  • Event Date Posted
    2016-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149136
  • 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 report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the electronic medical record (emr).
  • Action
    MERGE sent an Urgent Medical Device Recall letter dated February 9, 2016, to all affected customers via email or via certified mail if they did not have an e-mail address for the customer. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. For further questions, please call (800) 724-5970 ext. 8027.

Device

Device Recall Merge Cardio software
  • Model / Serial
    Versions 10.1 and 10.1.1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.