Events

Recall of RADSUITE / ICONNECT VNA / ICONNECT SHARE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MERGE HEALTHCARE INCORPORATED.

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
    31236
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    This recall has been initiated because of an error when viewing prior results. a pixel offset issue can occur when prefetching a prior image from the lta to a local cache resulting in the viewer being unable to display it. the original study on the lta is unaffected.

Device

RADSUITE / ICONNECT VNA / ICONNECT SHARE
  • Model / Serial
    Model Catalog: 40020 (Lot serial: >10 CONTACT MANUFACTURER)
  • Product Description
    MERGE ICONNECT ENTERPRISE ARCHIVE (ICEA)
  • Manufacturer
    MERGE HEALTHCARE INCORPORATED

Manufacturer

MERGE HEALTHCARE INCORPORATED