| TGA Action ID |
RC-2025-RN-00917-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Full Body UVB Therapy Unit
Software-Version: xx_2.0.39/2.01
Part No. 4557 N-LINEpro UVB 311nm
Part No. 4558 N-LINEpro UVA
Part No. 4559 N-LINEpro Universale
Serial Numbers: 455723-0000107, 455725-0000202, 455725-0000101 |
| ARTG Number |
371303 |
| Unique Device Identifier (UDI) |
4065258010054 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
MEDlight GmbH reports a rare case of rapid, unusual user actions including the entry of an mJ value instead of a J value, the non-observance of visual and acoustic warnings regarding both the dose and the duration of treatment (manual override of a soft stop by the user) and the non-monitoring of the application by the user.
This operating sequence could have led to an unintended UV overexposure of the patient, which could result in patient harm including burns. |
| Instructions for Customers/Users |
Customers are to:
- Enter dose in the software in J/cm² and refrain from selecting doses in the unit range mJ/cm².
- Observe and check warning notices.
- MEDlight will provide a software update for the affected products, which will prevent treatment from starting even if the warning messages are ignored in situations similar to the one described above (hard stop).
This action has been closed out on 23/06/2026 |
| Action Commencement Date |
29/10/2025 |
| Responsible Entity |
|
| Contact Information |
02 9620 7723 - Allied Biotech |