| TGA Action ID |
RC-2025-RN-00054-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Quanta System - User Manual of Youlaser MT & Quanta System - Shelase handpiece of Youlaser MT
Quanta System - User Manual of Youlaser MT
Product Code: DGM001123.07
ARTG 203773
(Aussie Medi Tech Pty Ltd - General/multiple surgical diode/carbon dioxide laser system)
Quanta System - Shelase handpiece of Youlaser MT
Serial Number: SQS1141-0717, SQS1520-0719, SQS1624-1020
ARTG 295573 - Cancelled |
| ARTG Number |
203773 |
| Action Type |
Recall |
| 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 Australian Register of Therapeutic Goods (ARTG). The review found there was insufficient clinical evidence to support the therapeutic use and long-term safety of these devices.
The Youlaser MT User Manual has been updated to remove the genitourinary and vaginal rejuvenation indications, as these indications are no longer approved for use on this device.
The associated Shelase handpieces used with the Youlaser MT are no longer approved and are to be removed from the market.
This recall only impacts the Shelase component of your YouLaser MT unit. All other Youlaser MT device applications such as dermatology and other specialties remain valid and can used as described according to the updated user manual.
|
| Instructions for Customers/Users |
Customers are to immediately stop use of the Shelase handpiece.
The Shelase handpiece will be deactivated in the Youlaser MT software by Aussie Medi Tech.
Customers are to contact Aussie Medi Tech on 02 9979 3730 in the first week of February 2025 to schedule the deactivation of the Shelase feature in the Youlaser MT software.
This deactivation will be completed on site and once the deactivation is complete, customers are to discard the affected handpiece as per local policy.
Customers are to refer to the NEW 2025 user manual document reference DGM001666.0 which will be emailed to affected customers.
The updated user manual has removed the genitourinary and vaginal rejuvenation indications as these indications are no longer approved for this device.
This action has been finalised on 7/5/2025. |
| Action Commencement Date |
28/01/2025 |
| Responsible Entity |
|
| Contact Information |
1300 25 70 20 - Aussie Medi Tech |