SL75/5 Linear Accelerator 의 안전성 경고

Safety alert

2012-08-29

2012-08-29

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120829.html

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.