| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01101-1 |
| Product Name/Description |
MultiDiagnost Eleva with Flat Detector Systems
(Fluoroscopic diagnostic digital x-ray system)
Product codes: 708037 & 708038
ARTG Number 98560 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |