FDAFDA · Food and drugs·Recall number Z-1611-2014
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)
Published May 21, 2014 · Recall initiated: March 5, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Distributor
- US Nationwide Distribution in the state of OH
- Lot
- monitor p/n 6802F-PA00001 module p/n 115-001704-00/M51A-30-80876
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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