Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430. Intended for intra hospital use under the direct supervision of a healthcare practitioner for the monitoring of various human physiological parameters.
FDA Recall Z-1785-2010 · Posted 2010-06-10
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Recalling FirmMindray DS USA, Inc., dba Datascope Patient Monitoring
Recall StatusTerminated
Product CodeMHX
Date Initiated2010-04-28
Date Terminated2011-06-22
Product Quantity24 US, 17 International
Reason for Recall
An issue with the Passport V Monitor has been identified where the Arrhythmia Analysis, ST Analysis and Invasive Blood Pressure functions are not operational.
Firm Action
Mindray issued Corrective action letters directly to all customers beginning April 28, 2010 by certified mail, return receipt requested. consignees were informed of the affected product.
For further information, contact Mindray DS USA, Inc. at 1-201-995-8391.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- United States (OH, TX, AZ, NY, MO, IL, FL and TN), Spain, Indonesia, Brazil, Italy, Columbia and British West Indies.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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