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Mindray DS USA, Inc. dba Mindray North America recalls DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, s
Recalled May 21, 2014 · FDA recall Z-1611-2014 · Mindray DS USA, Inc.
Hazard
The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing. · FDA Class II
Units
4 units
Sold at
US Nationwide Distribution in the state of OH
Description
The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
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)
Manufacturer(s)
Mindray DS USA, Inc. dba Mindray North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →