| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00188-1 |
| Product Name/Description |
iMDsoft MetaVision ICU (MV-ICU), Version 5.47.4622
(graphical patient information system used for data collection, management, and storage)
ARTG Number: 165518 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
22/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
A software issue has been identified in the medication management module which may lead to duplication of medication dose under specific settings. This can only occur when a medication order has a weekly interval (e.g., administer medication X every Monday) and an attribute (e.g, dose quantity or frequency) of the order is subsequently modified. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A temporary mitigation was provided by means of modifying the software configuration setting. Specifically, the proposal was to extend the time horizon from 7 days, which is equal to the dose interval, to greater than 7 days. A permanent solution will be provided once it becomes available. |
| Contact Information |
FSN@imd-soft.com |