Device product
Merge Cardio software.
Z-1486-2017
Product summary
- Event
- Event 76431
- Status
- Terminated
- Classification
- Class II
- Quantity
- 217 sites potentially have the affected versions
- Official record key
device-enforcement:Z-1486-2017
Official wording
Reason: Cardio study list does not show STAT studies without refreshing.
Code information: Versions 9.0; 9.0.1; 9.0.2; 9.0.3; 9.0.4; 9.0.5; 9.0.6; 9.0.7, 9.0.8, 9.0.9, 10.0, 10.0.1, 10.1, 10.1.1, and 10.1.2.
Distribution pattern: Distribution was nationwide to medical facilities. There was also military distribution. There was no foreign/government distribution.
Derived failure modes
-
Unknown
Cardio study list does not show STAT studies without refreshing.