| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00734-1 |
| Product Name/Description |
SuperLUX Pro and UltraLUX Pro
Serial numbers G10L01E1101; G10L01E1104; G10L01E1105; A10K03E1101; E10J08E0401; E10J08E0403; F10L01E2209; B0301104039D
ARTG 295158
(The Global Beauty Group - Intense pulsed light skin surface treatment system) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
When in the IPL Acne Treatment mode, a programming error in the software may result in the maximum output energy of 50J/cm2 instead of the output energy selected by the user and displayed on the machine.
As a result, the patient could receive burns to the skin and require medical treatment during IPL acne treatment.
No other serial numbers of SuperLUX Pro or UltraLUX Pro or any other products supplied by The Global Beauty Group are affected. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
When in the IPL Acne Treatment mode, a programming error in the software may result in the maximum output energy of 50J/cm2 instead of the output energy selected by the user and displayed on the machine.
As a result, the patient could receive burns to the skin and require medical treatment during IPL acne treatment.
No other serial numbers of SuperLUX Pro or UltraLUX Pro or any other products supplied by The Global Beauty Group are affected. |
| Contact Information |
0420350894 - Naerelle Dekker, Head of Product Development |