| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01267-1 |
| Product Name/Description |
DRX Revolution Mobile X-Ray System
Serial numbers: 101 to 764
ARTG number: 194055 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Carestream Health Australia Pty Ltd has received a report that an overseas service engineer observed a loose boom arm during routine maintenance on a DRX Revolution Mobile X-Ray System as one of three bolts that secure the boom to the carriage had fractured and the other two bolts were loose causing the boom arm to become loose. No other reports of this type have been received since the device was introduced into commercial distribution in 2009.
It was determined from the engineering assessment that the bolts installed in this specific carriage were not tightened to the required torque spec which could cause bolt failure due to bending fatigue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Carestream Health Australia is arranging for a service visit to affected customers to identify loose booms and replace carriage attachment bolts. This action has been closed-out on 07/06/2016. |
| Contact Information |
1300 651 786 - Carestream Health Australia |