| TGA Action ID |
RC-2025-RN-00045-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
INDIBA Elite NS Systems and INDIBA Intracavitary Capacitive Handle, INDIBA Intracavitary Capacitive Electro Pack and INDIBA Aesthetic Gynaecology Pack
Multiple product codes and serial numbers
ARTG 206260
(Indiba Australia Pty Ltd - Skin contouring system generator, radio-frequency) |
| ARTG Number |
206260 |
| 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.
Specific indications in the IFU related to the genitourinary use of the ELITE NS devices have been removed from the IFU. Accessories with specific indications for genitourinary use will be removed from the market. |
| Instructions for Customers/Users |
Recall:
Customers are to stop use of the affected handpieces and accessories immediately. The INDIBA Australia Pty Ltd will arrange for the collection of all affected handpieces/accessories and provide a full refund.
Product Defect Correction:
A new updated IFU to remove references to the genitourinary indications and vaginal rejuvenation, which are no longer approved, will be provided to customers. The IFU update is expected by end of January 2025.
Devices affected will be updated with a new software version to remove all genitourinary protocols. This software update will be done remotely.
This action has been finalised on 23/04/2025. |
| Action Commencement Date |
24/01/2025 |
| Responsible Entity |
|
| Contact Information |
0434 020 100 - Indiba Australia |