Merge Healthcare, Inc. recalls Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.

Recall date

February 9, 2016

Source

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

Recall number

Z-2709-2016

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).

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 Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.