Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 35238 |
| Brand Name: | Soltive Fibres |
| Model: | Models - TFL-FBX150BS 150, TFL-FBX150BS 200, TFL-FBX150BS 365, TFL-FBX150BS 550, TFL-FBX150BS 940, Soltive Pro Superpulsed Laser Unit, Soltive Premium Superpulsed Laser Unit |
| Affected: | all lot numbers |
| 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 identified reportable malfunctions and serious injuries, including breakage of a fibre that resulted in a burn to the hand of the user and a single-use fibre that caught on fire causing a procedural delay. There is no evidence that material within the operating room progressed to a fire in any of the reported incidents. The preliminary results of the investigation indicate that a fibre break, at the strain relief or along the length of the fibre, is the cause of, or contributes to, these incidents. The manufacturer is continuing to investigate the issue and will take appropriate actions regarding the investigation findings. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Wholesale |
| Date Commenced: | 19/5/2025 |
