Fujifilm Medical Systems U.S.A., Inc. recalls FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software vers…

Recall date

February 4, 2015

Source

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

Recall number

Z-1611-2015

FDA classification

Class II

Brand / firm

Fujifilm Medical Systems U.S.A., Inc.

Sold / distributed

Worldwide Distribution - US including CA, FL, IL, IN, MD, MI, MN, MO, NC, NY, OH, OR, PA, PR, TX, VA, WI Foreign: Canada

Why it was recalled

Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1