| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00085-1 |
| Product Name/Description |
DRX Revolution Mobile X-Ray System
Serial Numbers: 101 to 2545
ARTG Number: 194055 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
Carestream Health Australia Pty Ltd has received a report of unintended motion of a DRX Revolution Mobile X-Ray System caused by a loose pivot screw in the drive handle. There was no resulting injury. No other reports of this type have been received since the device was introduced into commercial distribution in 2009, however this problem could manifest itself in additional units over the lifetime of the device. If this failure was to recur in the field, the likelihood of injury would be mitigated by both bump stop and Estop systems on the device – which the driver/operator could use. However, given the weight of the device and the speed at which it can travel, should the device make contact with a person, the subsequent collision or crushing injury could be serious e.g. fractured/broken bones. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Carestream is advising users that they will be inspecting affected serial numbers and replacing the lower handle assembly and internal side covers of the device. In the interim, the device can continue to be used; however it is recommended that routine user inspections of the drive are continued and should any part show a visual problem or fail to operate as expected, the device should be removed from use and a service call placed to Carestream.
This action has been closed-out on 01/03/2018. |
| Contact Information |
02 9919 4562 - Carestream |