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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 Posted February 11, 2013
Recall Status1 Terminated 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/
Manufacturer
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah NJ 07430
800-2882121
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
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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