Events

Recall of FOCAL SOFTWARE CD

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
    62796
  • Event Risk Class
    II
  • Event Initiated Date
    2010-10-28
  • 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
    For xio imrt plansusing the dymamic mlc delivery option.The focal application will display all beam gantry angles set to zero degrees. the isodose display is still correctly represented for the true angles of the beams. focal is incorrectly looking at the angles stored per segments and not per beam. if this occurs it could result in serious injury or significant health consequences.

Device

FOCAL SOFTWARE CD

Manufacturer

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