| TGA Action ID |
RC-2025-RN-00936-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Genium / Genium X3
Model Numbers: 3B1-2*, 3B1-3* / 3B5-2*, 3B5-3*
Multiple serial numbers |
| ARTG Number |
286460 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
The battery status lights on the charger may lead users to assume that the battery is fully charged when it is not.
An anomaly in the battery management system incorporated into the Genium/Genium X3 has been identified where, if the prosthesis is not sufficiently charged by the user, there can be an unexpected activation of the ‘empty battery mode’ and the prosthesis will enter ‘safe mode’.
Ottobock have updated the battery management system so that the fifth LED will only be lit once the device is 100% charged. |
| Instructions for Customers/Users |
The battery management system of the prosthesis will be updated so that the fifth LED will only be lit once the device is 100% charged.
Users will be contacted by their prosthetist when the next inspection and service is due, and a replacement prosthetic knee joint will be provided to allow for continued mobility.
Customers are to:
Follow the Instructions for Use to charge the battery. This will ensure the knee joint always enters ‘safe mode’ if the device battery is depleted.
This action has been finalised on 4/11/2026. |
| Action Commencement Date |
13/11/2025 |
| Responsible Entity |
|
| Contact Information |
0409 190 248 - Otto Bock Australia |