Merge Healthcare, Inc. recalls Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and…

Recall date

October 26, 2015

Source

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

Recall number

Z-0554-2016

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Distributed in the states of IL, NC, and VT.

Why it was recalled

The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.

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 Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.