Merge Healthcare, Inc. recalls Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

Recall date

April 4, 2016

Source

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

Recall number

Z-1415-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

US Distribution was made to medical facilities in CA, FL, IL, MD, MO, OH, OK, TX, VT, and WI. Military distribution was also made.

Why it was recalled

A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.

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 using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.