FDA-Device2015-03-25Class II
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.
Mindray DS USA, Inc. dba Mindray North America
Hazard
An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement
Sold states
Nationwide Distribution
Affected count
519 units
Manufactured in
800 MacArthur Blvd, Mahwah, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1280-2015Don't want to check this manually?
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