Medical device recalls Moderate risk

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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