Recall Z-0742-2013— Mindray DS USA, Inc. d.b.a. Mindray North America

Name: FDA recall Z-0742-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-05

Class II · Terminated

Class II FDA medical device recall by Mindray DS USA, Inc. d.b.a. Mindray North America, initiated 2012-09-05, terminated 2013-10-22. It names one FDA 510(k) clearance: K053234. Product: Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.. Reason: Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available..

Recalling firm: Mindray DS USA, Inc. d.b.a. Mindray North America
Classification: Class II
Status: Terminated
Initiated: 2012-09-05
Terminated: 2013-10-22
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K053234 — PM-9000 EXPRESS PATIENT MONITORShenzhen Mindray Bio-Medical Electronics Co., Ltd.·cleared 2006-05-04

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 DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.

Reason for recall

Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.

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