Merge Healthcare, Inc. recalls Merge HEMO software.

Recall date

July 2, 2012

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2341-2016

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Merge HEMO software.