Recall Z-0513-2013— Mindray DS USA, Inc. d.b.a. Mindray North America

Name: FDA recall Z-0513-2013
Creator: U.S. Food and Drug Administration
Published: 2010-08-11

Class II · Terminated

Class II FDA medical device recall by Mindray DS USA, Inc. d.b.a. Mindray North America, initiated 2010-08-11, terminated 2013-08-02. It names one FDA 510(k) clearance: K092449. Product: DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), 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: There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations..

Recalling firm: Mindray DS USA, Inc. d.b.a. Mindray North America
Classification: Class II
Status: Terminated
Initiated: 2010-08-11
Terminated: 2013-08-02
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 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), 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

There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations.

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