Device product
Merge HEMO software.
Z-2341-2016
Product summary
- Event
- Event 74577
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37
- Official record key
device-enforcement:Z-2341-2016
Official wording
Reason: The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7
Code information: Software versions 8.10, 9.10, 9.20.
Distribution pattern: The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.
Derived failure modes
-
Unknown
The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7