| TGA Action ID |
RC-2025-RN-00358-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
SOLTIVE Pro SuperPulsed Laser System, SOLTIVE Premium SuperPulsed Laser System, TFL Premium Laser Unit & TFL Standard Laser Unit
Model Numbers: TFL-SLS, TFL-PLS, TFL-CPLU, TFL-CSLU
Item Codes: R5000769, R5000768 |
| ARTG Number |
344431 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Olympus issued a Safety Alert in February 2024 (RC-2024-RN-00071-1) reminding Soltive Users that the Procedure Treatment Parameters are guidelines Only. On September 2024, Olympus issued a Product Notification (RC-2024-RN-00789-1) pertaining to a Spanish and Portuguese Translation error in the Soltive Laser System Preset Treatment Parameters.
Olympus is now issuing a software update to adjust the treatment parameters of Procedure Presets for Lithotripsy and Manual Mode. The translation error will also be corrected through this software update. |
| Instructions for Customers/Users |
Olympus is releasing a software update and updating the IFU.
Customers are to:
- schedule with an Olympus Representative to perform the software upgrade onsite
- read the letters from the previous 2 market actions and continue to follow any appropriate actions performed
This action has been finalised on 2/10/2025. |
| Action Commencement Date |
1/04/2025 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Australia Customer Operations |