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U.S. Department of Health and Human Services

Class 2 Device Recall Passport V Monitor

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  Class 2 Device Recall Passport V Monitor see related information
Date Initiated by Firm April 28, 2010
Date Posted June 10, 2010
Recall Status1 Terminated 3 on June 22, 2011
Recall Number Z-1785-2010
Recall Event ID 55572
510(K)Number K091834  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc., dba Datascope Patient Monitoring
800 Macarthur Blvd
Mahwah NJ 07430
For Additional Information Contact Diane Arpino
201-995-8391
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = DATASCOPE CORP., PATIENT MONITORING DIVISION
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