Alerta De Seguridad para Precise Digital Accelerator, Synergy Platform, Synergy, Synergy S, Infinity, Axesse (Various Models, All lot no.)

Safety alert

2011-12-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20111214a.html

Field safety notice: elekta precise digital accelerator, synergy platform, synergy, synergy s, infinity, axesse (various models, all lot no.) medical device manufacturer, elekta limited, has issued a field safety notice on precise digital accelerator, synergy platform, synergy, synergy s, infinity, axesse, linear accelerator systems. a small number of reverse modulator diodes, a component in the equipment room of the linear accelerator, have ruptured. customers have heard a loud explosion in the equipment room sometime after beam termination. the patient and clinical operators are not at risk. a service engineer, or any personnel entering the equipment room could sustain serious injury. elekta reported that no incidents involving personnel have occurred. elekta has communicated with the users about the fitting of a reverse diode cover and advised that personnel who enter the equipment room should wear protective safety glasses before the cover is fitted. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier.