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.
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