Merge Healthcare, Inc. recalls DR Systems Unity PACS software, now known as Merge Unity PACS
- Recall date
- April 8, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1426-2017
- FDA classification
- Class II
- Brand / firm
- Merge Healthcare, Inc.
- Sold / distributed
- US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution.
Why it was recalled
Reports were missing demographic header information when they were faxed to referring physicians.
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
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