FDA-Device2016-08-10Class II
Merge HEMO software.
Merge Healthcare, Inc.
Hazard
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
Sold states
The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.
Affected count
37
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
Merge HEMO software.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2341-2016Don't want to check this manually?
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