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U.S. Department of Health and Human Services

Class 2 Device Recall DPM Central Monitoring System

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  Class 2 Device Recall DPM Central Monitoring System see related information
Date Initiated by Firm November 28, 2012
Date Posting Updated February 11, 2013
Recall Status1 Terminated 3 on August 15, 2013
Recall Number Z-0798-2013
Recall Event ID 64114
510(K)Number K080192  
Product Classification System,network and communication,physiological monitors - Product Code MSX
Product Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.
Code Information Part No Serial No, 300BF-PA00002 EH-17000037, 300BF-PA00002 EH-17000032, 300BF-PA00002 EH-17000033, 300BF-PA00002 EH-25000099, 300BF-PA00002 EH-18000043, 300BF-PA00003 EH-1A000072, 300BF-PA00002 EH-22000088, 300BF-PA00003 EH-1A000073, 300BF-PA00002 EH-12000060, 300BF-PA00002 EH-17000038, 300BF-PA00003 EH-21000077, 300BF-PA00002 EH-18000058, 300BF-PA00002 EH-23000096, 300BF-PA00003 EH-19000059, 300BF-PA00003 EH-19000060, 300BF-PA00002 EH-18000051, 300BF-PA00002 EH-12000054, 300BF-PA00002 EH-16000029, 300BF-PA00002 EH-11000052, 300BF-PA00002 EH-17000039, 300BF-PA00003 EH-1A000064, 300BF-PA00002 EH-18000050, 300BF-PA00003 EH-13000078, 300BF-PA00003 EH-13000085, 300BF-PA00002 EH-18000053, 300BF-PA00002 EH-17000036, 300BF-PA00002 EH-17000031, 300BF-PA00003 EH-17000040, 300BF-PA00002 EH-18000054, 300BF-PA00002 EH-1A000069, 300BF-PA00002 EH-12000062, 300BF-PA00002 EH-21000076, 115-006908-04 Software Kit, 300BF-PA00003 EH-13000083, 300BF-PA00003 EH-13000084, 300BF-PA00003 EH-22000087, 300BF-PA00002 EH-18000056, 300BF-PA00002 EH-17000035, 300BF-PA00002 EH-18000048, 300BF-PA00002 EH-18000052, 300BF-PA00003 EH-21000081, 300BF-PA00002 EH-17000030, 115-006908-03 Software Kit, 115-006908-03 Software Kit, 115-006908-03 Software Kit, 300BF-PA00003 EH-19000062, 300BF-PA00002 EH-18000057, 300BF-PA00003 EH-22000083, 300BF-PA00002 EH-11000051, 300BF-PA00002 EH-18000041, 300BF-PA00002 EH-21000082..
Recalling Firm/
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah NJ 07430
For Additional Information Contact Ms. Diane Arpino
Manufacturer Reason
for Recall
Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.
FDA Determined
Cause 2
Software design
Action Mindray North America/ Mindray DS USA Inc. sent an "URGENT PRODUCT CORRECTION ACTION" letter dated November 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your Mindray Service Representative at 1-800-288-2121 for questions relating to this issue.
Quantity in Commerce 51 units
Distribution Nationwide Distribution.
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 and Original Applicant = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD