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

Recall date

January 30, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0137-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.

Why it was recalled

The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up.

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

What was recalled

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