Events

Recall of ELEKTA PRECISE TREATMENT SYSTEM - MAIN UNIT

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
    17879
  • Event Risk Class
    II
  • Event Initiated Date
    2015-01-06
  • 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
    Elekta has identified a batch of securing bolts that fix the gantry counter frame weight stack may fail the potentially faulty bolts are marked with "of" on the top. the gantry counter frame weight stack is secured with 6 bolts. the original customer complaint reported that two of the bolts on the machine holding the counter frame sheared within a week of installation.

Device

ELEKTA PRECISE TREATMENT SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: MRT 6011 (Lot serial: S/N: 153602)
  • Product Description
    ELEKTA PRECISE TREATMENT SYSTEM
  • Manufacturer
    ELEKTA INC.

Manufacturer

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