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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 Recall
DPM Central Monitoring System
see related information
Date Posted February 11, 2013
Recall Status1 Terminated on August 15, 2013
Recall Number Z-0798-2013
Recall Event ID 64114
Premarket Notification
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/
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
800-288-2121
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
DESIGN: 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 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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