| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00704-1 |
| Product Name/Description |
DRX Revolution Mobile X-Ray System
Serial Numbers: 101 to 2623
ARTG Number: 194055 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Carestream Health Australia Pty Ltd has received a report of the tube and yoke assembly of a DRX Revolution Mobile X-Ray System separating, caused by 4
missing mounting screws in the assembly – not installed at the time of manufacturing. There was no resulting injury. There is a remote possibility of this failure occurring in another DRX Revolution Mobile X-Ray System and the likelihood of injury would be mitigated by both bump stop and E-stop 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 installing the mounting screws should they be missing. The device can continue to be used normally until the inspection has been conducted.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9919 4562 - Carestream Health |