| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00839-1 |
| Product Name/Description |
Kodak DirectView DR 7500 (Diagnostic x-ray system)
All batches Manufactured between 2005 and 2011
ARTG Number: 136112 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
31/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Carestream Health Australia Pty Ltd has received advice that there was an incident overseas where the Beta Assembly (x-ray tube and collimator) detached from the Overhead Tube Crane (OTC) telescope, falling onto the patient who was injured, requiring hospitalisation. No other reports of this type have been received since the device was introduced into commercial distribution in 2005. Carestream Health has determined that this incident occurred due to the part that holds the Beta Assembly to the OTC telescope not being properly assembled at the time of manufacture. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Carestream Health Australia Pty Ltd is arranging for inspection of all the affected units and will conduct a repair if required. This action has been closed-out on 19/02/2016. |
| Contact Information |
02 9240 8963 - Carestream Health Australia Pty Ltd |