| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00610-1 |
| Product Name/Description |
Horizon Medical Imaging products versions 4.5 up to and including 11.9 and McKesson Radiology 12.0 (Radiology picture archiving and communication system)
ARTG Number: 158895 (TBC) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, McKesson has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images. This discrepancy occurs on a very small percentage of studies, and may result in the following:
- A small number of images, typically a single image, in an individual study may be lost or unavailable; and/or
- The study is not archived in long-term storage without manual correction of the discrepancy.
If the issue occurs, it is possible that clinical decisions will be made using an incomplete set of images. This may result in inappropriate care leading to patient harm and/or a need to retake images. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
McKesson will provide a resolution to this issue through a software update which may require changing your software version. A Device Technology Australia representative will contact customers to organise the software upgrade. Thia action has been closed-out |
| Contact Information |
1800 084 734 - Device Technologies Technical Support |