| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00458-1 |
| Product Name/Description |
iLED 3/5, TruLight 3000/5000, Helion, TruVidia SD, TruVidia HD, VidiaPort Surgical Lighting, Camera and Monitoring Systems
All Serial Numbers
ARTG Numbers: 200921, 200946, 200943, 200945,170219, 170545 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Trumpf Medical has been notified by its supplier that there is potential for fatigue fractures to develop in welds of spring arms over time when subject to extreme forces. There is a risk the monitor could fall and swing freely on the swing arm and strike a person or object. There have been no reports of injuries as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Trumpf Medical is advising users that if the systems are due for biennial maintenance, to contact the authorised service provider to schedule the preventative maintenance.
If the biennial maintenance is not due, and the service provider did not inspect the welds during the previous maintenance, contact the service provider to schedule a service call to inspect the welds.
Requirements to inspect the welds during biennial maintenance can be found in the User Manual.
This action has been closed out on the 26/09/2018. |
| Contact Information |
1800 445 576 - Trumpf Medical |