Medical device recalls Moderate risk

Merge Healthcare, Inc. recalls Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiologic…

Recall date
April 4, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1457-2017
FDA classification
Class II
Brand / firm
Merge Healthcare, Inc.
Sold / distributed
US Nationwide Distribution.

Why it was recalled

In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.

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. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.

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