| TGA Action ID |
RC-2025-RN-00096-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Alma FermiLift Applicators
Product Codes: AACO13011590 /AACO23111570/AACO17111361
Serial Numbers: M2018021 & CO2S1422
ARTG 177041 (cancelled) |
| ARTG Number |
|
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Following a post-market review of energy-based devices used for vaginal rejuvenation, the Pixel CO2 (FemiLift) applicators, used for Genitourinary Syndrome of Menopause (GSM), Vulvovaginal Atrophy (VVA), and Stress Urinary Incontinence (SUI), were found to be non-compliant with the Essential Principles (EPs) set out in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002.
Specifically, the devices lacked sufficient evidence to substantiate safety and efficacy for these indications, as determined by the Therapeutic Goods Administration (TGA) during a post-market review. |
| Instructions for Customers/Users |
Customers should:
1. Stop or cease use of the affected recall product.
2. Identify and locate the affected products concerned by this recall procedure.
3. Collect and put in quarantine Pixel CO2 (FemiLift, FemiLift Slim, FemiTight, FemiLift Smart) applicators concerned by this recall procedure.
4. For any ongoing patient management, please ensure that treatments align with validated indications and discontinue use or promotion of these applicators for the cancelled indications.
NB: Getz Healthcare will arrange the collection of the affected devices. |
| Action Commencement Date |
18/02/2025 |
| Responsible Entity |
|
| Contact Information |
(02) 9413 6209, qara.au@getzhealthcare.com - Getz Quality Department |