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U.S. Department of Health and Human Services

Class 2 Device Recall DPM Central Station

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 Class 2 Recall
DPM Central Station
see related information
Date Posted January 03, 2013
Recall Status1 Terminated on February 19, 2013
Recall Number Z-0630-2013
Recall Event ID 63616
Premarket Notification
510(K) Number
K080192 
Product Classification System,Network And Communication,Physiological Monitors - Product Code MSX
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.
Code Information 510 K K080192 P/N 300BF-PA200002
Recalling Firm/
Manufacturer
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah, New Jersey 07430
For Additional Information Contact Ms. Diane Arpino
201-995-8407
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
Action Mindray sent a Product Corrective Action letter dated May 12, 2012, to all affected customers via certified mail return receipt requested to two medical facilities. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the issue would be corrected through a softweare upgrade of the affected product. A Mindray Service Representative would contact their facility to arrange for the software upgrade at no cost to them. For questions regarding this recall call 1-800-288-2121.
Quantity in Commerce two units
Distribution Nationwide Distribution including OH and GA
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MSX and Original Applicant = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
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