Class 2 Device Recall DPM Central Station

• Date Initiated by Firm: May 12, 2011
• Date Posted: January 03, 2013
• Recall Status: Terminated on February 19, 2013
• Recall Number: Z-0630-2013
• Recall Event ID: 63616
• 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
• FEI Number: 2221819
• Recalling Firm/ Manufacturer: Mindray DS USA, Inc. d.b.a. Mindray North America; 800 MacArthur Blvd.; Mahwah NJ 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: 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MSX