Medical device recalls Moderate risk

Merge Healthcare, Inc. recalls Merge LIS software.

Recall date
March 5, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0399-2017
FDA classification
Class II
Brand / firm
Merge Healthcare, Inc.
Sold / distributed
Distribution was made nationwide and to the Virgin Islands. Foreign distribution was made to the Bahamas.

Why it was recalled

There is a potential for duplicate container numbers to be created for patients.

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 software.

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