| TGA Action ID |
RC-2025-RN-00089-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
FemiLift, FemiLift Slim, FemiLift Smart and FemiTigh
FemiLift Applicator
Part Number: AACO17111361
Serial Number: M4320073
FemiLift Smart Applicator
Multiple part numbers and serial numbers
ARTG 323941
(Alma Lasers Australia Pty Ltd - Dermatological carbon dioxide laser system) |
| ARTG Number |
323941 |
| Action Type |
Recall |
| Action Level |
Retail |
| Hazard Classification |
Class II |
| Reason for the Action |
The Pixel CO2 handpieces (FemiLift, FemiLift Slim, FemiLift Smart and FemiTight) used for treating Genitourinary Syndrome of Menopause (GSM), Vulvovaginal Atrophy (VVA), and Stress Urinary Incontinence (SUI) were found to be non-compliant with Essential Principles of safety and performance as determined during a post-market review.
The use of devices for these unvalidated indications may pose risks, including:
- Ineffectiveness of treatment.
- Potential misuse due to insufficient safety data and lack of validated clinical protocols. |
| Instructions for Customers/Users |
Alma clients, clinics, and healthcare providers have been notified of the recall of Pixel CO2 (FemiLift) applicators used for GSM, VVA, and SUI, and all the affected handpieces have been collected.
Customer have also been supplied the updated IFU which removed unapproved indications. |
| Action Commencement Date |
6/02/2025 |
| Responsible Entity |
|
| Contact Information |
franca@alma-lasers.com.au - Alma Lasers Australia |