Merge Healthcare, Inc. recalls Merge OrthoPACS software.

Recall date

May 24, 2017

Source

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

Recall number

Z-2620-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution.

Why it was recalled

A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.

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 OrthoPACS software.