MultiDiagnost Eleva with Flat Detector Systems(Fluoroscopic diagnostic digital x-ray system) 의 리콜

Recall

RC-2014-RN-01101-1

Class I

2014-10-10

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01101-1

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 fluoroscopy images or exposures. in case the fluoroscopy pedal is bent and live fluoroscopy is not available, the exposure pedal of the footswitch or the hand switch may be used to generate a live image in order to finish a procedure, this will lead to a higher dose but it outweighs the potential safety risk.

Philips Healthcare is advising the customers to check the footswitch for bent pedals before the start of a procedure and if bent pedals are found the procedure should not continue and local Service should be contacted. Philips Healthcare is performing the hardware update of the Footswitch in order to prevent bent pedals and therefore prevents an intermittent or continuous inability of making live fluoroscopy images or exposures. This action has been closed-out on 11/08/2016.