Mar

2015

Cl II Passport V Monitor

Company:Mindray DS USA, Inc. dba Mindray North America
Date of Enforcement Report: 3/25/2015
Class lI:

PRODUCT

VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following 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. Recall Number Z-1280-2015

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

RECALLING FIRM/MANUFACTURER
Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ on 1/23/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
519

DISTRIBUTION
Nationwide.

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Passport V Monitor

Amy Sellers

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