Recall Z-0630-2013— Mindray DS USA, Inc. d.b.a. Mindray North America

Name: FDA recall Z-0630-2013
Creator: U.S. Food and Drug Administration
Published: 2011-05-12

Class II · Terminated

Class II FDA medical device recall by Mindray DS USA, Inc. d.b.a. Mindray North America, initiated 2011-05-12, terminated 2013-02-19. It names one FDA 510(k) clearance: K080192. Product: DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.. Reason: There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient..

Recalling firm: Mindray DS USA, Inc. d.b.a. Mindray North America
Classification: Class II
Status: Terminated
Initiated: 2011-05-12
Terminated: 2013-02-19
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K080192 — HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·cleared 2008-04-03

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 Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

Reason for recall

There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.

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