Medical device recalls Moderate risk

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

Recall date
April 4, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1176-2017
FDA classification
Class II
Brand / firm
Merge Healthcare, Inc.
Sold / distributed
Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution.

Why it was recalled

Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.

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, Hartland, WI.

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