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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