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

Recall date

October 8, 2015

Source

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

Recall number

Z-0878-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Distribution was made to medical facilities in CA, CO, CT, MA, MD, MN, MT, NE, NV, NY NJ, PA, SC, WA, and WI. Foreign distribution was made to Canada, as well as other countries.

Why it was recalled

Measurements in the software are changing after saving a plan with a measurement result, 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 OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.