Company: Mindray DS USA
Date of Enforcement Report 1/9/2013
Class ll:
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. Recall Number Z-0630-2013
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/MANUFACTURER
Mindray DS USA, Inc. d.b.a. Mindray North America, Mahway, NJ on 5/12/2011. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Nationwide
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