Recall Z-2737-2015— Mindray DS USA, Inc. dba Mindray North America

Name: FDA recall Z-2737-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-27

Class II · Terminated

Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2015-07-27, terminated 2017-05-02. It names one FDA 510(k) clearance: K092449. Product: Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.. Reason: The DPM 7 Monitors may display a black screen..

Recalling firm: Mindray DS USA, Inc. dba Mindray North America
Classification: Class II
Status: Terminated
Initiated: 2015-07-27
Terminated: 2017-05-02
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

Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.

Reason for recall

The DPM 7 Monitors may display a black screen.

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