Medical device recalls Moderate risk

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

Recall date
May 25, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0611-2017
FDA classification
Class II
Brand / firm
Merge Healthcare, Inc.
Sold / distributed
Distribution was made to medical facilities nationwide. Foreign distribution was also made.

Why it was recalled

Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.

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