Events

Safety Alert for SL75/5 Linear Accelerator

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
    2012-08-29
  • Event Date Posted
    2012-08-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120829.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 sl75/5 linear accelerator the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning all sl75/5 linear accelerator, manufactured by elekta. according to the manufacturer, there was malfunction of the semikron diode of sl75/5. this diode is fitted as charging diode d8 but can also be fitted as reverse diode d7 on later machines. they can be found on the modulator chassis assembly. if a malfunction of the semikron diode occurs, the ceramic body of the diode can rupture. this can cause ceramic material and silicone oils to eject from the modulator assembly which may cause injury to on-site service personnel. there are currently no reported incidents of this kind on sl75/5 machines. furthermore, the manufacturer recommends that: service personnel should always wear protective safety glasses, when they do work on the modulator assembly with the covers removed. users should make sure the door of the modulator chassis assembly is closed when the digital accelerator is in operation. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 29 august 2012.

Device

SL75/5 Linear Accelerator
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Elekta SL75/5 Linear Accelerator
  • Manufacturer
    Elekta

Manufacturer

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