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U.S. Department of Health and Human Services

Class 2 Device Recall Mindray DS USA Inc. DPM 6 Monitor.

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  Class 2 Device Recall Mindray DS USA Inc. DPM 6 Monitor. see related information
Date Initiated by Firm March 05, 2014
Date Posted May 13, 2014
Recall Status1 Terminated 3 on April 27, 2015
Recall Number Z-1611-2014
Recall Event ID 67932
510(K)Number K092449  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM)
Code Information monitor p/n 6802F-PA00001  module p/n 115-001704-00/M51A-30-80876 
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 MacArthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact Ms. Diane Arpino
800-2882121
Manufacturer Reason
for Recall		 The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
FDA Determined
Cause 2		 No Marketing Application
Action Mindray DS Usa Inc. contacted their sole customer via phone on March 5, 2014. The affected products will receive software upgrade.
Quantity in Commerce 4 units
Distribution US Nationwide Distribution in the state of OH
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 = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
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