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

Recall date

January 31, 2016

Source

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

Recall number

Z-2627-2016

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Distribution was made to AL, AZ, CA, IL, MD, MA, MI, MO, NV, NJ, NC, OH, PA, TN, and VA. Government distribution was made to OK. There was no foreign/military distribution.

Why it was recalled

Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport.

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

What was recalled

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