Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00943-1
Product Name/Description	MultiDiagnost Eleva and MultDiagnost Eleva with Flat Detector (diagnostic fluoroscopic x-ray system) MultiDiagnost Eleva Product Code: 708032 MultiDiagnost Eleva with Flat Detector Product Code: 708034 MultiDiagnost Eleva Product Code: 708036 MultiDiagnost Eleva with Flat Detector Product Code: 708037 MultiDiagnost Eleva with Flat Detector Product Code: 708038 ARTG Number: 98560
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/07/2016
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	The two bolts that attach the clamping plate to the lateral shaft may break. This may cause the C-arm to float freely. Depending on the orientation of the free-floating C-arm and any other forces applied to it, the C-arm could move laterally forward, slide out of its bearings and then possibly sag. The sagging C-arm can strike a patient or operator. However, the probability of this occurring is rare. There have been no reports of injury associated with this event.
Recall Action	Recall for Product Correction
Recall Action Instructions	Philips is advising users to be aware of the issue. If the C-arm moves in an unexpected manner, users should contact Philips immediately. Philips will be implementing a repair of the C-arm as a permanent correction. This action has been closed-out on 28/06/2017.
Contact Information	1800 251 400 - Philips Customer Care Centre