Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Elekta SL75/5 Linear Accelerator

29 Aug 2012

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:

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

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