Medical device recalls Moderate risk

Merge Healthcare, Inc. recalls Merge PACS software. The firm name on the label is Merge Healthcare.

Recall date
April 4, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1431-2017
FDA classification
Class II
Brand / firm
Merge Healthcare, Inc.
Sold / distributed
USA (nationwide ) Distribution was made to medical facilities. Internationally to Canada. There was no government or military distribution.

Why it was recalled

Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.

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 PACS software. The firm name on the label is Merge Healthcare.

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