Events

Recall of INTELEPACS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTELERAD MEDICAL SYSTEMS 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
    34576
  • Event Risk Class
    II
  • Event Initiated Date
    2016-08-05
  • 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
    Intelerad has identified a software problem in the image fusion module which may display an incorrect calculation of standard uptake value (suv) when loading the presentation state of image for a previously calculated (and saved) region of interest (roi).

Device

INTELEPACS

Manufacturer

INTELERAD MEDICAL SYSTEMS INCORPORATED