| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00523-1 |
| Product Name/Description |
DX-D 600 Digital Radiography System (general purpose x-ray system)
Products affected: DX-D 600 Digital Radiography System, DX-D 600 Automatic Systems, DX-D 600 Semi-Automatic Systems
All serial numbers affected
ARTG Number:173861 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Agfa has received a report in which the mechanical detent marker on a DX-D 600 became detached.
There have been no reports of injuries associated with this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Agfa HealthCare is advising users that if the mechanical detent markers have become loose, to notify Agfa as soon as possible. Agfa will be inspecting all affected units and correcting where required.
This action has been closed on the 14/09/2018 |
| Contact Information |
1300 364 612 - Agfa HealthCare Service Help Desk |