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)
FDA Recall Z-1611-2014 · Posted 2014-05-13
Recalling FirmMindray DS USA, Inc. dba Mindray North America
Recall StatusTerminated
Product CodeMHX
Date Initiated2014-03-05
Date Terminated2015-04-27
Product Quantity4 units
Reason for Recall
The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
Firm Action
Mindray DS Usa Inc. contacted their sole customer via phone on March 5, 2014. The affected products will receive software upgrade.
Root Cause
No Marketing Application
Distribution Pattern
US Nationwide Distribution in the state of OH
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.