| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00689-1 |
| Product Name/Description |
Horizon Medical Imaging Products Versions 4.6.1 up to and including 11.9 and McKesson Radiology 12.0 (Radiology picture archiving and communication system)
ARTG Number: 158895 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
McKesson has identified a rare software issue when two or more processes attempt to modify the same image folder within fractions of a second, the write lock mechanism may fail to prevent concurrent modification of the same data. This may result in loss of data within the image folder. As both simultaneous write access and lock mechanism failures are rare, the likelihood of experiencing this problem is very low. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The manufacturer, McKeeson Medical Imaging, will provide a software update to resolve this issue. Until the issue is resolved end users are advised to ensure that all expected images are present in a study prior to completing the Technologist workflow. Thia action has been closed-out on 28/01/2016 |
| Contact Information |
02 9975 5755 - Device Technologies Australia Pty Ltd |