| TGA Action ID |
RC-2026-RN-00148-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Rifton TRAM and E-Pacer Patient Transfer and Gait Training Devices
Rifton TRAM
Model Number: K310
Production Date: Jul 2012 to Oct 2020
ID Code: K31020120731AA to K31020201009AA
Rifton TRAM
Model Number: K320
Production Date: Oct 2013 to Nov 2020
ID Code: K32020131014AA to K32020201023AB
Rifton E-Pacer
Model Number: K660
Product Date: Jun 2017 to Apr 2018, Mar 2019 to Nov 2020
ID Code: K66020170712AB to K66020201020AB |
| ARTG Number |
340726, 358470 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
A potential safety problem has been identified with the Rifton TRAM and E-Pacer patient transfer devices relating to the body support strap assembly. In units produced using aluminium stampings from a 2019 batch, a change in the manufacturing process resulted in sharper strap opening edges. These edges may abrade the strap over time, causing fraying and possible failure. Strap failure could lead to a fall and injury. |
| Instructions for Customers/Users |
Distributors are to:
- immediately inspect their stock and quarantine affected stock on hand to prevent further distribution.
Consumers are to:
- monitor the product for fraying of the body support system straps and not to use the product if fraying is visible.
Apex Mobility will supply a replacement body support kit for installation by customers. Once the kit is installed, discard the old body support.
This action has been finalised on 8/7/2026. |
| Action Commencement Date |
10/03/2026 |
| Responsible Entity |
|
| Contact Information |
1300 212 192 – Apex Mobility |