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)
- Recall Initiated
- March 5, 2014
- Posted
- May 13, 2014
- Terminated
- April 27, 2015
- Recall Number
- Z-1611-2014
- Quantity
- 4 units
- Firm Location
- Mahwah, NJ
Reason for Recall
The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
Distribution
US Nationwide Distribution in the state of OH
Lot / Code Info
monitor p/n 6802F-PA00001 module p/n 115-001704-00/M51A-30-80876
Root Cause
No Marketing Application
Action Taken
Mindray DS Usa Inc. contacted their sole customer via phone on March 5, 2014. The affected products will receive software upgrade.
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