| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01247-1 |
| Product Name/Description |
DX-D 600 X-ray System, Versions below 3.6
All full automatic & semi-automatic devices below version 3.6
ARTG Number: 173861 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
The unit is equipped with safety measures to ensure no movement can occur without user interaction. However, a customer complaint reported that during normal movement’s isolated cases of unintended Overhead Tube Crane acceleration occurred. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised that in the case of an accelerated movement, release the button/pedal immediately to stop the unit and notify their Agfa HealthCare service contact at once. Agfa Healthcare will be upgrading all full automatic and semi-automatic DX-D 600 devices to Version 3.6 to eliminate this issue. This action has been closed-out on 12/08/2016. |
| Contact Information |
1300 364 612 - Agfa HealthCare Service Help Desk |