| TGA Action ID |
RC-2025-RN-00456-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
DR 100s Mobile X-Ray System
Serial Number:10002; 10229; 10231; 10246; 10247; 10248; 10289; 10290
Product codes: 6013/100 |
| ARTG Number |
296282 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Between 2021 and 2024, Agfa Australia went onsite to inspect the battery component of 8 units of DR 100s mobile X-ray system. Swollen batteries were replaced as they were recharged with inappropriate voltage for too long. And Firmware update V1.00.02 for the Battery Charger Board was installed for all affected devices to avoid a battery defect due to frequent overcharging.
To date there have been no injuries reported as a result of this problem.
This action was undertaken prior to TGA notification. |
| Instructions for Customers/Users |
Agfa Australia inspected the batteries, replaced swollen batteries, updated Battery Charger Board Firmware to V1.00.02 to prevent overcharged batteries.
This action was closed out on 22/07/2025. |
| Action Commencement Date |
24/06/2025 |
| Responsible Entity |
|
| Contact Information |
1300 364 612 – Customer Service Department |