Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27973 |
| Brand Name: | Soltive System |
| Model: | TFL-PLS SOLTIVE Premium SuperPulsed Laser System - All Serial numbers |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Olympus (NZ) Ltd 15D Paul Matthews Road Albany Auckland |
| Contact Information: | 0508 659 6787 |
| Manufacturer: | Gyrus ACMI Inc |
| Issue: | The manufacturer has received reports of patient injury associated with the Soltive Laser System, when used in dusting and fragmentation of ureteral stones. The investigations revealed a user likely exceeded the 20W standard presets for stone dusting and fragmentation when treating impacted stones in the ureter and ureteropelvic junction. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/7/2021 |
