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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Event Detail

Event ID 63616
Product Type Devices
Status Ongoing
Recalling Firm Mindray DS USA, Inc. d.b.a. Mindray North America
City Mahwah
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-05-12
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including OH and GA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 510 K K080192 P/N 300BF-PA200002 Class II 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. two units Z-0630-2013