Recall Z-1611-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. dba Mindray North America
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
| Date | May 13, 2014 (initiated Mar 5, 2014) |
| Status | Terminated |
| Reason | The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing. |
| Root cause | No Marketing Application |
| Action | Mindray DS Usa Inc. contacted their sole customer via phone on March 5, 2014. The affected products will receive software upgrade. |
| Quantity | 4 units |
| Distribution | US Nationwide Distribution in the state of OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092449 | BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5 Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Aug 30, 2010 |