XVI R4.0 to R4.2.1, R4.5.0, R4.5.1 and R5.0.0 to R5.0.1 의 안전성 경고

Safety alert

2014-07-22

2014-07-22

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140722.html

Medical device safety alert: elekta xvi r4.0 to r4.2.1, r4.5.0, r4.5.1 and r5.0.0 to r5.0.1 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice (fsn) concerning xvi r4.0 to r4.2.1, r4.5.0, r4.5.1 and r5.0.0 to r5.0.1, manufactured by elekta. the user does an online volumeview acquisition and registration. the user accepts the registration and the “table move assistant” dialog box appears. two different scenarios mentioned in the fsn can result from the same error. this issue may cause clinical mistreatment and collision risk resulting in fatal injury to the patient. the manufacturer advises users of the followings: monitor the “relative actual” and “absolute actual” columns of the “table move assistant” dialog box, if these values are blank do not press the table asu buttons on the function keypad (fkp); or if users see a movement larger than the “relative actual” and the “absolute actual” does not update, they should follow the procedure mentioned in the fsn to correct the error. when doing volumeview acquisitions with an external bld attached, users should make sure that the stop angle of the volumeview parameters is in the lower half of the gantry rotation. this decreases the risk of a collision with the patient. a later software release of xvi will be supplied which gives a solution to this problem. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con433868 if you are in possession of the product, please contact your supplier for necessary actions. posted on 22 jul 2014.