Medical device recalls Moderate risk

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

Recall date
November 17, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1180-2017
FDA classification
Class II
Brand / firm
Merge Healthcare, Inc.
Sold / distributed
US Distribution was made to medical facilities in AL, IN, MI, PA and WI.

Why it was recalled

The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or 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 RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

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