| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00402-1 |
| Product Name/Description |
Fraxel Dual 1550/1927 Laser Systems
Model Number: MC-SYS-SR1500-D
Multiple serial numbers affected
ARTG Number: 141041 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
Solta Medical Australia has determined that some customers may have obsolete versions of Fraxel Dual Laser Labelling (User Manual and Treatment Settings Card).The two obsolete documents incorrectly provided parameter settings for the treatment of melasma using the 1927 nm wavelength laser. Only the 1550 nm wavelength has approved indications for use for the treatment of melasma.While both issues were corrected prior to 27 October, 2010, customers may not have received a corrected version of the labelling.
-Revision A of the 10-05170 re: store DUAL User Manual, released on 27 August,2009 incorrectly stated the 1927 nm laser was indicated for melasma.This was corrected on revision B of 10-05170.
-MK 3100 revisions A and B, Fraxel re: store DUAL Laser Treatment settings card, effective from 2nd December 2009 - 27th October 2010 incorrectly stated the 1927 nm laser was indicated for melasma.This error was corrected on revision C of MK 3100. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Solta Medical Australia is requesting their customers to return affected versions of the User Manual or Treatment Settings Card. Replacement information will be provided to customers. |
| Contact Information |
0432 715 264 - SOLTA Medical Customer Service |