Apex Collimator 의 안전성 경고

Safety alert

2013-02-05

2013-02-05

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130205a.html

Medical device safety alert: elekta apex collimator the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning apex collimator manufactured by elekta limited. according to the manufacturer, if the apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates. the inhibit may or may not show in the tcs restrictions list in the view restrictions dialog box, but it still prevents the machine movements. if the touchguard button is used to override the inhibit and rotate the gantry, the apex collimator may disconnect from the radiation head and cause serious injury and damage to the equipment. elekta recommends the users to follow the advice as mentioned in the field safety notice to solve the problem. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con226996 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 february 2013.