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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 Recall
Mindray DS USA Inc. DPM 6 Monitor.
see related information
Date Posted May 13, 2014
Recall Status1 Open
Recall Number Z-1611-2014
Recall Event ID 67932
Premarket Notification
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, New Jersey 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
PREMARKET APPROVAL: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
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