| TGA Action ID |
RC-2026-RN-00150-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Olympus SOLTIVE SuperPulsed Laser System
SOLTIVE Pro SuperPulsed Laser System
Model/SKU: TFL-SLS/ R5000769
SOLTIVE Premium SuperPulsed Laser System
Model/SKU: TFL-PLS/ R5000768
TFL Premium Laser Unit
Model/SKU: TFL-CPLU
TFL Standard Laser Unit
Model/SKU: TFL-CSLU
Multiple Serial Numbers |
| ARTG Number |
344431 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Olympus has received ninety-eight (98) complaints reporting an abrupt loss of power or functionality of the SOLTIVE SuperPulsed Laser System, or an inability to power on the unit. Investigation determined that a potential defect in the 24V power supply module in some SOLTIVE Laser units may cause the system to become inoperable.
In some cases, smoke or a burning smell may occur. By design, any smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
There is no evidence of any patient injury associated with these complaints. |
| Instructions for Customers/Users |
Customers are to examine their inventory and identify any of the affected devices listed in Appendix A.
An Olympus representative will reach out to coordinate the replacement of 24V power supply module in the affected units. In the meantime, customers may continue using their SOLTIVE Laser until the repair is completed.
This action has been closed out on 14/10/2026 |
| Action Commencement Date |
27/02/2026 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |