Events

Recall of PRECISEPLAN SOFTWARE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ELEKTA 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
    33123
  • Event Risk Class
    II
  • Event Initiated Date
    2008-02-06
  • 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
    Two conditions may cause the user to unintentionally modify a locked fraction group when using the "beam edit" function to modify a beam in an unlocked fraction group.

Device

PRECISEPLAN SOFTWARE
  • Model / Serial
    Model Catalog: MRT 7161 (Lot serial: ); Model Catalog: MRT 7131 (Lot serial: )
  • Product Description
    Elekta PrecisePlan
  • Manufacturer
    ELEKTA INC.

Manufacturer

ELEKTA INC.
  • Manufacturer Address
    ATLANTA
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    HC