Merge Healthcare, Inc. recalls Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a p…

Recall date

January 30, 2016

Source

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

Recall number

Z-2865-2016

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

Patient information in the header is only found on the first page of the report and not on the subsequent pages.

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. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.