| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01250-1 |
| Product Name/Description |
TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia Lighting and Video Systems
Multiple Products and Serial Numbers
ARTG Numbers: 200921, 170219 and 170545 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
Trumpf Medical has received information stating the iLED and TruLight lighting systems have fallen from the central axis. The reported incidents occurred while the lights were being positioned for surgical procedures and have been involved in one injury to a user. The investigation of this issue has determined
the root cause is due to the improper installation of the snap ring that can occur when a spring arm is attached to the central axis. The snap ring is located inside the interface and holds the spring arm in place. If the snap ring is installed improperly, the spring arm of the lighting system can descend over time, and eventually fall from the central axis. When the snap ring has been installed properly, the potential for the lighting system to fall does not exist. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hill-Rom is providing users with work around instructions to follow as an interim measure. Hill-Rom will be inspecting affected units and providing additional labelling as a permanent measure.
This action has been closed out on 25/10/2018 |
| Contact Information |
02 9562 0900 - TrumpfMedical Australia |