| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00860-1 |
| Product Name/Description |
MetaVision ICU (MV-ICU)
Version 5.47 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
iMDSoft has identified a software bug in MetaVision 5.47 which appears when switching between patients or users. It can cause a refresh error which has the potential to cause confusion to healthcare providers reviewing patient information. This bug can lead to the title bar reflecting the previous patient details while the remainder of the patient data on screen refreshes, this causes a data mismatch and an error message to occur. The message presents the user with an option of 'Retry’ or 'ignore'. If the user chooses 'ignore' it allows the data mismatch to continue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Until a permanent solution is available, users are advised to choose 'abort' should they see this error occur which causes a system restart and forces a data refresh, in parallel with their routine Patient Identification processes. Users are advised that when they move between patients or change users that they must check to ensure the patient matches the patient information on the title bar of the application.
It is anticipated that a new version of the MetaVision software which fixes the software bug mentioned above will be released on 20 September 2015 and will be then available for installation. This action has been closed-out on 17/08/2016. |
| Contact Information |
1800 240 919 - iMDsoft |