Events

Recall of XIO RADIATION TREATMENT PLANNING SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ELEKTA BUSINESS AREA SOFTWARE SYSTEMS IMPAC MEDICAL SYSTEMS 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
    19977
  • Event Risk Class
    II
  • Event Initiated Date
    2015-08-28
  • 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
    The manufacturer has discovered that xio will calculate wedge dose in the region outside of the physical and the linac will deliver open dose. the patient will receive dose that is different from the planned dose and that dose difference can exceed 5%. there is a remote probability of serious injury resulting from this issue.

Device

XIO RADIATION TREATMENT PLANNING SYSTEM

Manufacturer

ELEKTA BUSINESS AREA SOFTWARE SYSTEMS IMPAC MEDICAL SYSTEMS INC.
  • Manufacturer Address
    MARYLAND HEIGHTS
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    HC