Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16497 |
| Brand Name: | Solta Fraxel Dual 1550/1927 Laser System |
| Model: | |
| Affected: | |
| Software version: | |
| Recalling Organisation: | New Zealand Medical & Scientific Ltd Level 4, Building 10 666 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 09 259 4062 |
| Manufacturer: | Solta Medical Inc |
| Issue: | The manufacturer advises that some versions of the operating instructions has incorrect information regarding the treatment of melasma using 1927nm. The instructions were corrected in later information but some customers may not have received updated versions of the documents. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 7/4/2014 |
