Events

Safety Alert for MLCi and MLCi2 radiation heads

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
    2012-04-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120423a.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
    Field safety notice: elekta mlci and mlci2 radiation heads medical device manufacturer, elekta limited, has issued a field safety notice concerning all mlci and mlci2 radiation heads. according to elekta, it is possible that the backup diaphragms drive mechanism can become loose after many years in clinical operation. this can cause a backlash between the positioning mechanism and the diaphragm. this backlash can be seen by the usual x-ray and field calibration checks when the field is moved from a small to a large field size. if there is a problem it will be that the backup diaphragm is not in the correct position behind the mlc leaf tips. if the affected customers do not do the recommended planned maintenance program, screws can become lost from the positioning mechanism. as the problem can lead to clinical mistreatment if it is not repaired, customers are advised to conduct a weekly recommended physics check of the x-ray and light field size calibration to make sure the field is moved from a small to a large field size. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

MLCi and MLCi2 radiation heads
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Elekta MLCi and MLCi2 radiation heads
  • Manufacturer
    Elekta Limited

Manufacturer

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