| TGA Action ID |
RC-2025-RN-00147-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
RFDE-VA “THERMIVA” Electrode |
| ARTG Number |
298909 |
| Action Type |
Recall / Product Correction |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
i-Medix Pty Ltd, is notifying customers of the removal of the of RFDE-VA “THERMIVA” Electrode from the ARTG register.
The decision to recall the RFDE-VA was made due to lack of evidence supporting its use in gynaecological procedures.
In addition, customers will be informed of changes in the IFU regarding the reduction in the claimed indications especially the ThermiRF Temperature Controlled RF System and its accessories which are not intended for gynecological procedures including but not limited to the treatment of sexual dysfunction and/or urinary incontinence and vulvovaginal laxity. |
| Instructions for Customers/Users |
Recall:
Customers should stop using the ThermiVa electrode for the treatment of gynaecological
procedures including but not limited to the treatment of sexual dysfunction and/or
urinary incontinence and vulvovaginal laxity.
Product Correction:
An updated IFU, which removes references to the genitourinary indications and vaginal rejuvenation, which are no longer approved, will be provided. |
| Action Commencement Date |
17/03/2025 |
| Responsible Entity |
|
| Contact Information |
info@i-medix.com.au |