| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00484-1 |
| Product Name/Description |
iLED 7, VidiaPort and Trulight Products
Multiple Products, Product Codes, Serial Numbers and UDI Numbers
ARTG's 408361, 407000 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Baxter Healthcare has received customer reports of thermal skin injuries when using the iLED 7 surgical light system products. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads.
Thermal injuries may include skin burns and drying of tissue that may lead to scarring, infection, and/or internal organ damage. Baxter has received 10 reports of serious injury associated with this problem to date. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Baxter is updating the IFU to add situations that can result in thermal skin injury and highlight residual risks due to overhead light usage, which will be provided when available. Baxter is working on a product resolution and additional information will be provided when available
Users can continue to use affected product by following the current IFU while considering:
-Utilising lowest possible illumination level suitable for the procedure
-Avoid overlapping light fields set at high intensity (80% or higher)
-If a very high-intensity setting is temporarily required, reduce intensity as soon as the need passes.
-Ensure the Adaptive Light Control (ALC) Plus sensor is activated and indicated on the wall/mobile control panel. If activation of the ALC Plus is not possible contact a technical service representative
-If the ALC Plus is switched off, the light-head must be positioned 100 cms from the surgical field. At other distances the illuminance/irradiance limits can be exceeded |
| Contact Information |
1800 445 576 - Baxter Healthcare Customer Service |