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U.S. Department of Health and Human Services

Class 2 Device Recall V Series Monitor

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  Class 2 Device Recall V Series Monitor see related information
Date Initiated by Firm May 07, 2012
Date Posted August 28, 2012
Recall Status1 Terminated 3 on July 17, 2013
Recall Number Z-2279-2012
Recall Event ID 62880
510(K)Number K102004  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product V Series Patient Monitors; Mindray DS USA, Inc.

Product Usage:
The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements; Heart Rate; Pulse Oximetry (SpO2); ST Segment Analysis; Arrhythmia Detection; Non Invasive Blood Pressure (NIBP); Invasive Blood Pressure (IBP); Cardiac Output (CO); Respiratory Gasses; Respiration Rate; and Temperature. The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. The target populations are adult, pediatric and neonate with the exception of: Arrhythmia detection and ST Segment Analysis, for which the target populations are adult and pediatric only; IV Drug Calculations for which the target population is adult only; and Cardiac Output for which the target population is adult and pediatric only.
Code Information V Series Monitor Part Numbers 0998-00-1800-101 and 0998-00-1800-201.
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah NJ 07430
For Additional Information Contact Ms. Diane Arpino
201-995-8407
Manufacturer Reason
for Recall		 Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed between September 31, 2010 and January 9, 2012.
FDA Determined
Cause 2		 Software design
Action Mindray sent an Urgent: V Series Monitoring System Correction letters dated May 7, 2012 via certified mail to all affect customer. The letter identified the affected product, problem and actions to be taken. Customers are directed that VPS modules should not be used between systems until a software upgrade has been completed. This work will be done at no cost to the customer. For questions contact your Mindray Serviice Representative at 1-800-288-2121.
Quantity in Commerce 979 units
Distribution Worldwide Distribution - US Nationwide including the states of: NY, SD, NE, IL, MO, CA, OH, OK, WA, IN, WY, CO, TX, FL, NC, AL and Puerto Rico. and the countries of: Australia, Canada, Columbia, New Zealand, Pakistan, Russia, Saudi Arabia, United Kingdom and Venezuela.
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 = MINDRAY DS USA, INC.
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