Events

Recall of Fusion Workstation

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
    75425
  • Event Risk Class
    Class 2
  • Event Number
    Z-0294-2017
  • Event Initiated Date
    2011-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150241
  • 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
    After a period of time running fusion workstation, the hounsfield measurement tool will report incorrect values.
  • Action
    The recalling firm initiated phone calls to affected sites beginning 1/30/2016.

Device

Fusion Workstation
  • Model / Serial
    Versions V3.0.2 P3, 3.02, 3.1, 3.2, 3.3, and 3.3.1.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.
  • Product Description
    Fusion Workstation.; Indicated for the transmission and review of radiological images.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.