| TGA Action ID |
RC-2025-RN-00004-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Votiva, InMode Pro, Empower RF with FormaV or Morpheus8V Handpieces
Multiple Product numbers and serial numbers |
| ARTG Number |
238736, 331683 |
| Action Type |
Recall / Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Claims related to genitourinary indications for laser and RF handpieces have been withdrawn and specifically excluded from use for these indications.
The handpieces are no longer approved for internal use and the user manuals are no longer compliant and must be replaced with revised versions.
update 24/07/2025:
·Updated indications for use of the FormaV is now only for noninvasive external use for the temporary relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
·Updated indications for use of the Morpheus8V is now only for noninvasive external use in dermatologic and general surgical procedures for electrocoagulation and haemostasis. |
| Instructions for Customers/Users |
Use of the handpieces for treatment for of stress urinary incontinence (SUI), non-surgical labioplasty, sexual dysfunction, pelvic floor weakness, genitourinary syndrome of menopause (GSM) or vulvovaginal atrophy (VVA), changes in aesthetic appearance of the female anatomy, dryness, itching, reduced elasticity, and burning during menopause must cease immediately.
Customers are requested to identify and remove all previous copies of the user manual from use and replace them with the revised version.
Updated training will be provided where appropriate.
Update 24/07/2025:
Customers who wish to return their handpieces (if only used for the non-approved indications) are to complete the Response Form and indicate whether they would like a suitable replacement.
If indicated to return and replace the affected handpieces, an InMode customer service representative will arrange a return and the provision of a suitable replacement handpiece. |
| Action Commencement Date |
3/02/2025 |
| Responsible Entity |
|
| Contact Information |
02 7209 5678 - InMode Australia |