Z-1785-2010

Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430. Intended for intra...

Name: Z-1785-2010 Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430. Intended for intra...
Creator: Mindray DS USA, Inc., dba Datascope Patient Monitoring
Published: 2010-04-28
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2010-04-28 / Terminated / root cause: software

FDA source

Mindray DS USA, Inc., dba Datascope Patient Monitoring began a recall of 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... on 2010-04-28. The reason FDA records is "An issue with the Passport V Monitor has been identified where the Arrhythmia Analysis, ST Analysis and Invasive Blood Pressure functions are not operational". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1785-2010
Status: Terminated
Initiated: 2010-04-28
Posted: 2010-06-10
Terminated: 2011-06-22
Recalling firm: Datascope Corp.
Product: 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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 24 US, 17 International
Distribution: Worldwide Distribution -- United States (OH, TX, AZ, NY, MO, IL, FL and TN), Spain, Indonesia, Brazil, Italy, Columbia and British West Indies.
Product codes and lots: Part Number 6100F: Domestic Serial Numbers: PV 02018-K9, PV02024-K9, PV02039-K9, PV01999-K9, PV02004-K9, PV02017-K9, PV02020-K9, PV01687-I9, PV01694-I9, PV01702-I9, PV02325-K9, PV02043-K9, PV01403-I9, PV01509-I9, PV01675-I9, PV02229-K9, PV02011-K9, PV02045-K9, PV02044-K9, PV02037-K9, PV02300-K9, PV01412-I9, PV01411-I9 and PV01695-I9; and Foreign Serial Numbers: PV01470-I9, PV01924-J9, PV0926-J9, PV01989-K9, PV01994-K9, PV01997-K9, PV02330-K9, PV02332-K9, PV02744-A0, PV03005-A0, PV03006-A0, PV03007-A0, PV01965-K9, PV01970-K9, PV01971-K9, PV02056-K9 and PV02057-K9.

Product code MHX

K091834Class IIPassport V Monitor, Model 0998-00-6100Datascope Corp., Patient Monitoring Division / cleared 2009-07-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)