Events

Recall of Merge Hemo Software Versions: 9.10, 9.20.0, 9.20.2, 9.30.0, 9.40.0, 9.40.1, 9.40.2 with Windows 7 OS

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
    75564
  • Event Risk Class
    Class 2
  • Event Number
    Z-0665-2017
  • Event Initiated Date
    2014-04-30
  • 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=150802
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • Reason
    The application may crash during the cath lab procedure.
  • Action
    Merge sent an Important Alert letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed to contact Merge Support at 866-261-5761 or support@merge.com. For questions regarding this recall call 877-741-5369.

Device

Merge Hemo Software Versions: 9.10, 9.20.0, 9.20.2, 9.30.0, 9.40.0, 9.40.1, 9.40.2 with Windows 7 OS
  • Model / Serial
    Versions 9.10, 9.20.0, 9.20.2, 9.30.0, 9.40.0, 9.40.1, and 9.40.2 with Windows 7 Operating System
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Merge Hemo software. || Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterization laboratories
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.