Merge Healthcare, Inc. recalls DR Systems Unity PACS software, now known as Merge Unity PACS software.
- Recall date
- October 15, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0939-2017
- FDA classification
- Class II
- Brand / firm
- Merge Healthcare, Inc.
- Sold / distributed
- Distribution was made to medical facilities located in MT, CA, PA, and TX.
Why it was recalled
The software fails to associate to the correct MG image if there are two images for the same view.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
DR Systems Unity PACS software, now known as Merge Unity PACS software.
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