Mindray DS USA, Inc. dba Mindray North America recalls Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital us…

Recall date

January 23, 2015

Source

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

Recall number

Z-1280-2015

FDA classification

Class II

Brand / firm

Mindray DS USA, Inc. dba Mindray North America

Sold / distributed

Nationwide Distribution

Why it was recalled

An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement

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

What was recalled

Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.