| TGA Action ID |
RC-2025-RN-00078-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Novavision - EVA Enhancer of Vaginal Anatomy
Serial Numbers: EVA1214, EVA1121, EVA1199
ARTG 293061 (Cancelled) |
| ARTG Number |
|
| 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 Novavision - EVA Enhancer of Vaginal Anatomy is intended to be used for genitourinary indications and vaginal rejuvenation, however this is no longer approved for use and the devices are to be removed from the market.
|
| Instructions for Customers/Users |
Customers are to immediately cease use of the affected devices.
An Aussie Medi Tech technician will visit customer to deactivate the system.
Once the deactivation is complete, customers are to discard the affected device as per local policy. |
| Action Commencement Date |
5/02/2025 |
| Responsible Entity |
|
| Contact Information |
1300 25 70 20 - Aussie Medi Tech |