| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00861-3 |
| Product Name/Description |
DRX Evolution System (digital diagnostic x-ray system)
All serial and lot numbers
All units manufactured since May 2010
ARTG Number: 136112 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
23/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
There is a possibility of gradual downward movement of the overhead tube crane in the event of a power loss. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Adjustment of crane and fitting of a clamp to the pulley to prevent loss of tension |
| Contact Information |
02 9420 8963 - Carestream |