Events

Safety Alert for Digital Accelerators with Electrons and Beam Modulator MLCi/MLCi2

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

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
    2013-07-05
  • Event Date Posted
    2013-07-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130705a.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 digital accelerators with electrons and beam modulator mlci/mlci2 the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning all digital accelerators with electrons and beam modulator, mlci/mlci2, agility or asymmetric heads, manufactured by elekta. according to the tga, the manufacturer has advised that some digital accelerators have increased electron applicator auto-tracking settings in the field, to values greater than the factory-set defaults, which can result in an increase of electron applicator radiation leakage in the patient plane, as well as around the applicator. the manufacturer is asking users to check all affected machines against the default auto-tracking settings. a software update will be provided as a permanent fix. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00667-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 july 2013.

Device

Digital Accelerators with Electrons and Beam Modulator MLCi/MLCi2
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Elekta Digital Accelerators with Electrons and Beam Modulator MLCi/MLCi2
  • Manufacturer
    Elekta

Manufacturer

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