Soltive System
- Recalling firm
- Olympus (NZ) Ltd
- Product
- Soltive System. [Device]. 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
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-02-26
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/a40c36ba-9f15-48c8-a722-c8ed259ac4e8