Merge Healthcare, Inc. recalls Merge LIS

Recall date

January 23, 2017

Source

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

Recall number

Z-0289-2021

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Domestic Distribution Only: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee, Texas.

Why it was recalled

A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.

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 LIS