| TGA Action ID |
RC-2025-RN-00618-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ETHEREA-MX and ATHENA
Product Code: CAP-ETHEREAMX, 22006HP |
| ARTG Number |
305169 |
| 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 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 genitourinary and vaginal rejuvenation indications for the ETHEREA-MX system are no longer approved by the TGA. The Instructions For Use (IFU) have been updated to reflect the reduced indication.
The associated accessory, ATHENA probe, needs to be returned for disposal immediately as it is no longer approved for its intended purpose. |
| Instructions for Customers/Users |
Customers are to:
- Return the associated ATHENA probe
- Review the amended IFU for the ETHEREA-MX system |
| Action Commencement Date |
16/07/2025 |
| Responsible Entity |
|
| Contact Information |
1300 346 448 - Cryomed Customer Service |