Events

Recall of Device Recall iConnect Access

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
    75497
  • Event Risk Class
    Class 2
  • Event Number
    Z-0611-2017
  • Event Initiated Date
    2016-05-25
  • 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=150545
  • 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
    Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.
  • Action
    The recalling firm issued a notification letter dated 1/27/2016 via email or via certified mail if the firm did not have an email address for the customer. Nonresponders were issued a second letter dated 5/25/2016 on 5/26/2016.

Device

Device Recall iConnect Access
  • Model / Serial
    Versions 3.0.1, 3.1, and 3.2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made to medical facilities nationwide. Foreign distribution was also made.
  • Product Description
    iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.