Device product
Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
Z-1457-2017
Product summary
- Event
- Event 76447
- Status
- Terminated
- Classification
- Class II
- Quantity
- 361 sites potentially have the affected versions
- Official record key
device-enforcement:Z-1457-2017
Official wording
Reason: In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.
Code information: Versions 6.10, 6.10.1, 6.10.2, 6.10.3, 7.10, 7.20, 7.20.1, 8.10.0, 8.20, 9.10.0, 9.20, 9.20.2, 9.20.3, 9.30, 9.40, 9.40.1, 9.40.2, and 9.40.3
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.