Merge Healthcare, Inc. recalls Merge Cardio software.
- Recall date
- April 4, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1486-2017
- FDA classification
- Class II
- Brand / firm
- Merge Healthcare, Inc.
- Sold / distributed
- Distribution was nationwide to medical facilities. There was also military distribution. There was no foreign/government distribution.
Why it was recalled
Cardio study list does not show STAT studies without refreshing.
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 Cardio software.
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