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Merge Healthcare, Inc. recalls Merge HEMO software.
Recalled August 10, 2016 · FDA recall Z-2341-2016 · Merge Healthcare
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 · FDA Class II
Units
37
Sold at
The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.
Description
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
Product
Merge HEMO software.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →