Print version of this report
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 Carestream Health Australia Pty Ltd
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