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U.S. Department of Health and Human Services

Class 2 Device Recall VSeries

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  Class 2 Device Recall VSeries see related information
Date Initiated by Firm May 19, 2014
Date Posted July 16, 2014
Recall Status1 Terminated 3 on April 20, 2017
Recall Number Z-2059-2014
Recall Event ID 68582
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
Code Information Part Number (P/N): 0998-00-1800-101 and 0998-00-1800-201 with software version 2.4.1.18 in use with 12-lead ECG Module, P/N:0998-00-1804-01 and 0998-00-1804-02.
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 MacArthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact
800-2882121
Manufacturer Reason
for Recall		 ECG interpretation feature issues. False measurements reported when the algorithm cannot determine P wave or QRS axis. The Median Complex Report displays the representative beat 25% larger than actual signal input. When a patient date of birth is imported from an external source, the ECG interpretation algorithm uses the default age of 50, and interpretive statements may be incorrect.
FDA Determined
Cause 2		 Software design
Action Mindray issued "Urgent: V-Series Monitoring System Corrective Action" notices dated May 19, 2014, to customers that received the affected product via certified mail with return receipt verification. The notification informs the customer of the issues with the affected product and how to identify the affected product. The notification recommends that customers discontinue use of the 12-lead ECG interpretation feature until a software correction is available (anticipate August 2014). A point of contact is provided to customers in case they have questions. For further questions please call 1-800-288-2121.
Quantity in Commerce 113 units (57 United States; 56 International)
Distribution Worldwide Distribution - US including the states of Louisiana, New Jersey, Montana, South Carolina and Wyoming.
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.
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