| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00101-1 |
| Product Name/Description |
Horizon Medical Imaging (HMI) products software versions 4.5 to and including 11.9 (Radiology picture archiving and communication system)
ARTG Number: 158895 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
28/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
During the archive procedure, if the system begins to archive images for multiple studies within fractions of a second and an unexpected condition causes the software process restart the following issues may occur:
1. Incorrect images being displayed for a study retrieved from archive (for example, a study for a different patient being displayed),
2. Failure to retrieve images for a study from archive.
If this issue occurs, two or more studies may be affected. This issue is not immediately evident to the user at the time of archival. It is possible that clinical decisions will be made using an incorrect set of images or an incomplete set of images. This may result in inappropriate care leading to patient harm if unnoticed or a need to retake images. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction. |
| Contact Information |
1800 429 551 - Device Technologies Australia |