| TGA Action ID |
RC-2026-RN-00659-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Imaging Ring
Serial numbers starting with SN2022-IRMxxxx, SN2023-IRMxxxx, SN2024-IRMxxxx, SN2025-IRMxxxx and SN2026-IRM001 to SN2026 IRM035 |
| ARTG Number |
370877 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Deeply discharged AGM or aged batteries may develop internal heating during recharging which may cause swelling of cells and eventually release of sulphur-containing gases, which emit a strong odour and are toxic if inhaled in higher concentration.
This action has been undertaken prior to notification to the TGA. |
| Instructions for Customers/Users |
Customers are to:
- Be aware that the system must be disconnected from the mains power supply immediately if
any unusual or strong odour (such as sulphur, burning, or chemical smells) is detected.
- Keep batteries always charged for longevity. The max storage time of batteries uncharged is 6 months. Long term storage shall be within the temperature, humidity and air pressure ranges specified in the Important Notice.
This action has been closed out on 28/09/2026 |
| Action Commencement Date |
28/08/2026 |
| Responsible Entity |
|
| Contact Information |
Michael.Wawrzyniak@elekta.com - Michael Wawrzyniak |