| TGA Action ID |
RC-2025-RN-00751-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
SmartXide CO2 Laser MonaLisa Touch Scanner
All product identifiers
90- (22mm and 18mm) and 360-degree Probes
Part numbers: N93501, N94601, N97701 |
| ARTG Number |
106780 |
| Action Type |
Recall / Product Correction |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
The TGA has completed a post-market review of all energy-based devices used for vaginal rejuvenation included in the ARTG. The review found there was insufficient clinical evidence to support this therapeutic use and the long-term safety of these devices.
The accessories (90- and 360-degree Probes) have been cancelled from ARTG 106780 by the TGA, meaning that they can no longer be lawfully supplied for commercial use in Australia and are now being recalled.
Genitourinary systems indications have been removed from the SmartXide CO2 Laser MonaLisa Scanner Instructions for Use (IFU). These indications are no longer approved for this device and are therefore now categorised as ‘off label’ uses. |
| Instructions for Customers/Users |
RECALL:
- Customers are to identify and quarantine any affected 90- (22mm and 18mm) and 360-degree Probes.
- Return the 90- (22mm and 18mm) and 360-degree Probes devices to the address in the customer letter to reconcile this recall.
For devices already supplied via the Special Access Scheme (SAS) refer to the customer letter for more information.
PRODUCT CORRECTION:
- Genitourinary system indications have been removed from the IFU.
- The scanners and handpieces used for other indications remain on ARTG.
- Review the updated IFU (provided by the sponsor), noting the removed genitourinary system indication.
- Place the letter and the updated IFU with the SmartXide CO2 Laser MonaLisa Touch Scanner. |
| Action Commencement Date |
29/08/2025 |
| Responsible Entity |
|
| Contact Information |
07 3008 9800 - High Tech Medical |