Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36590 |
| Brand Name: | Soltive System |
| Model: | Olympus SOLTIVE SuperPulsed Laser System (SOLTIVE Laser) products, models Pro (TFL-SLS) and Premium (TFL-PLS) |
| Affected: | Models/SKU - TFL-SLS/ R5000769, TFL-PLS/ R5000768, TFL-CPLU, TFL-CSLU |
| 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 complaints describing an abrupt loss of power and functionality of the SOLTIVE SuperPulsed Laser System, or an inability to power on the unit. The 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 also occur. By design, the issue causing any smoke or burning smell that is detected would be contained within the internal laser console enclosure and would be self-extinguishing. |
| Recall action type: | Correction |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 26/2/2026 |
