Medical device recalls Moderate risk

Merge Healthcare, Inc. recalls Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a card…

Recall date
March 28, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1091-2017
FDA classification
Class II
Brand / firm
Merge Healthcare, Inc.
Sold / distributed
Nationwide Distribution

Why it was recalled

There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.

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. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure

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