PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: May 21, 2014 Initiated: March 5, 2014 #Z-1611-2014

Product Description

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)

Reason for Recall

The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.

Details

Units Affected
4 units
Distribution
US Nationwide Distribution in the state of OH
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled? ▼
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). Recalled by Mindray DS USA, Inc. dba Mindray North America. Units affected: 4 units.
Why was this product recalled? ▼
The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 21, 2014. Severity: Moderate. Recall number: Z-1611-2014.

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