Recall Z-1611-2014— Mindray DS USA, Inc. dba Mindray North America

Name: FDA recall Z-1611-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-05

Class II · Terminated

Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2014-03-05, terminated 2015-04-27. It names one FDA 510(k) clearance: K092449. 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). Reason: The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing..

Recalling firm: Mindray DS USA, Inc. dba Mindray North America
Classification: Class II
Status: Terminated
Initiated: 2014-03-05
Terminated: 2015-04-27
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K092449 — BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·cleared 2010-08-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.