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
    76719
  • Event Risk Class
    Class 2
  • Event Number
    Z-1517-2017
  • Event Initiated Date
    2015-09-22
  • 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=154021
  • 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
    Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.
  • Action
    On 9/22/2015, the recalling firm issued letters dated 9/8/2015 and flagged "PRODUCT INFORMATION" via email to their customers. The recalling firm also issued letters dated 3/28/2016 via email the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. A letter dated 7/11/2016 was issued to nonresponders.

Device

Merge Cardio software
  • Model / Serial
    Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, and 9.0.8
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Merge Cardio software. || Product Usage: || Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.