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U.S. Department of Health and Human Services

Class 2 Device Recall Mindray BeneVision Distributed Monitoring System (DMS)

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  Class 2 Device Recall Mindray BeneVision Distributed Monitoring System (DMS) see related information
Date Initiated by Firm August 30, 2018
Create Date October 17, 2018
Recall Status1 Terminated 3 on December 20, 2018
Recall Number Z-0170-2019
Recall Event ID 81084
510(K)Number K162607  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Code Information This potential issue affects BeneVision DMS with software version 03.01.00 to 03.03.00
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 Macarthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact Ms. Diane Arpino
201-995-8407
Manufacturer Reason
for Recall		 The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG waveforms to appear as a flat line at the centralized viewing station and will manifest if more than 64 TD60 transmitters have been connected to a given central station server. Each central station supports only 32 transmitters at a time. For the issue to manifest, the BeneVision DMS needs to be configured to use flexible device assignment, have more than 64 TD60 transmitters, and the workflow must allow 64 TD60s to move around between multiple central stations in the same care area.
FDA Determined
Cause 2		 Software design
Action The firm notified affected consignees on August 30, 2018, via Urgent Medical Device Recall letter. The letter advised customers of the software issue when more than 64 telemetry transmitters have been connected to a central station. Customers were advised to use the system normally, but informed that a Mindray Service Representative would be in contact to arrange for a system software update to be performed at the customer site. Mindrays Technical Support team may be reached at (877) 913-9663 (Option 1), Monday through Friday, 8:30am - 5:30pm ET should you have technical questions. Customers were also asked to complete and return an attached Acknowledgement and Receipt Form.
Quantity in Commerce 5
Distribution Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.
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 = MHX and Original Applicant = Shenzhen Mindray Bio-Medical Electronics Co., Ltd
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