| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00182-1 |
| Product Name/Description |
Remote controls for JUPITER, ARTIS and TruSystem 7500 operating tables |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Trumpf Medical received reports that the operating tables sporadically moved independently and without the user deliberately pressing an operating element. No patients or users were injured. The investigations determined that the root cause was a button on a remote control which was mechanically damaged by external influences. As a result of the damaged button, specific vibrations or movements of the remote control can emit a valid movement command at any time, either continuously or sporadically.
This action was undertaken prior to the notification to the TGA. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Trumpf Medical is providing instructions as a supplement to the user manual and requesting the users to check the remote controls for visual damages.Trumpf Medical is requesting the customers to avoid using the remotes with visual damages to the key pads.Trumpf Medical is arranging the upgrade of the existing remote controls with a redesigned membrane keypad to eliminate the known mode of failure. This action has been closed-out on 19/02/2016. |
| Contact Information |
Trumpf Med Australia -1300 852 058 |