| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00226-1 |
| Product Name/Description |
Horizon Medical Imaging (HMI) product versions 4.6.1 up to and including 11.9 and McKesson Radiology (MR) 12.0 and 12.1.1
(Radiology Picture archiving and communication system)
ARTG Number: 158895 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that under rare circumstances, imported images and/or studies may re-use a non-unique image directory.
This issue may cause incorrect images to be displayed for a patient. It is possible that clinical decisions will be made using an incorrect set of images. If undetected, in the worst case this may result in inappropriate care leading to potential patient harm. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor DTA will contact the affected customers and arrange for the implementation of a software upgrade which will resolve the reported issue. |
| Contact Information |
02 8998 1861 - Device Technologies Australia |