Events

Safety Alert for Apex Collimator

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Elekta Limited.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-02-05
  • Event Date Posted
    2013-02-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130205a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: elekta apex collimator the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning apex collimator manufactured by elekta limited. according to the manufacturer, if the apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates. the inhibit may or may not show in the tcs restrictions list in the view restrictions dialog box, but it still prevents the machine movements. if the touchguard button is used to override the inhibit and rotate the gantry, the apex collimator may disconnect from the radiation head and cause serious injury and damage to the equipment. elekta recommends the users to follow the advice as mentioned in the field safety notice to solve the problem. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con226996 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 february 2013.

Device

Apex Collimator
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Elekta Apex Collimator
  • Manufacturer
    Elekta Limited

Manufacturer

Elekta Limited
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    DH