| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01269-1 |
| Product Name/Description |
DRX Revolution Mobile X-Ray System
All lot numbers affected
ARTG Number: 194055 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Carestream Health Inc has received reports of the below incidents:
- In the USA, the end cover of the DRX Revolution Mobile X-ray System column was dislodged when it was caught on an interfering object whilst the column was descending.
- Four occurrences in the USA of a communication failure between PC (host computer) and Communication I/O board (CIB) resulting in the generator not being reset after a successful exposure and image acquisition. This resulted in an exposure initiated by the user using the hand switch completing without the image being captured. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Carestream Health is installing a replacement end cap and software update to correct the issues. |
| Contact Information |
02 8962 4914 - Carestream Health Australia |