| TGA Action ID |
RC-2025-RN-01039-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
XVIVO Liver Assist
Model: 11.101 (All serial numbers)
Product Identifiers: 112404M512, 112412M526 |
| ARTG Number |
307528 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
The XVIVO Liver Assist MDR may experience the following problems:
- False “Backup Battery Low” and/or “Backup Battery Damaged” alarms
Four instances of a damaged battery and five battery low warnings have been reported. Examination of the machines involved has shown that no actual battery defect was present and that the warnings are false positives.
- Incorrect date and time settings
One instance of an incorrect time/date was reported, where the DatAssist files show the default year 1970. DatAssist is not part of the clinical operation of the device and is intended as a diagnostic tool for XVIVO R&D and service. While the wrong time and date may make it more difficult to identify a certain perfusion run, it does not affect the operation of the device.
- Elevated temperature without triggering an alarm
One case was reported where a temperature warning did not appear even though the temperature in the thermo circuit rose beyond the pre-set limits. |
| Instructions for Customers/Users |
Customers are to complete and return the response form. Upon receipt of a completed form, Stark Medical will arrange a suitable time to update the firmware.
This action has been closed out on 27/05/2026 |
| Action Commencement Date |
19/12/2025 |
| Responsible Entity |
|
| Contact Information |
1300 938 637 - Stark Medical |