Alerta De Seguridad para pedal of footswitch for philips multidiagnost eleva fd systems and allura xper systems

Safety alert

2014-07-11

2014-07-11

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140711.html

Medical device safety alert: pedal of footswitch for philips multidiagnost eleva fd systems and allura xper systems medical device manufacturer, philips healthcare, has issued a field safety notice concerning its footswitches for multidiagnost eleva fd systems and allura xper systems. according to the manufacturer, if a footswitch is frequently used on an anti-fatigue mat, on a not flat surface or in the pedestal, the footswitch pedals may get bent. this might cause an intermittent or continuous inability of making live fluoro images or exposures. in case the fluoro pedal is bent and live fluoro is not available, the exposure pedal of the footswitch or the handswitch may be used to generate a live image in order to finish a procedure. this will lead to a higher dose but it outweighs a possible safety risk. the manufacturer advises users that before the start of a procedure, the footswitch should be inspected for possible bent pedals. if bent pedals are found, the procedure should not continue. furthermore, the manufacturer would arrange a mechanical hardware update of the footswitch in order to prevent bent pedals. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 11 july 2014.