Recall Z-1280-2015— Mindray DS USA, Inc. dba Mindray North America

Name: FDA recall Z-1280-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-23

Class II · Terminated

Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2015-01-23, terminated 2017-04-20. It names one FDA 510(k) clearance: K091834. Product: 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.. Reason: An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement.

Recalling firm: Mindray DS USA, Inc. dba Mindray North America
Classification: Class II
Status: Terminated
Initiated: 2015-01-23
Terminated: 2017-04-20
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K091834 — PASSPORT V MONITOR, MODEL 0998-00-6100Datascope Corp., Patient Monitoring Division·cleared 2009-07-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.