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U.S. Department of Health and Human Services

Class 2 Device Recall Mindray DS USA

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  Class 2 Device Recall Mindray DS USA see related information
Date Initiated by Firm March 09, 2016
Create Date April 27, 2016
Recall Status1 Terminated 3 on April 19, 2018
Recall Number Z-1575-2016
Recall Event ID 73693
510(K)Number K150882  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Panorama Patient Monitoring Network
Mindray DS USA
The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside monitor.
Code Information Panorama Central Station's CPU Unit, Tower (p/n 0998-00-0709-01) Panorama Central Station's CPU Unit, 2U case (p/n 0998-00-0708-01) Panorama Centrall Station's eGateway Tower (p/n 0998-00-0709-03) Panorama Central Station's eGateway 2U case (p/n 0998-00-0708-03)
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
800-288-2121
Manufacturer Reason
for Recall		 Panorama Central Station including the work station View Station, View Station and the eGateway will revert to the year 2000 when Daylight Savings Time (DST) occurs on March 13, 2016, or under various conditions.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Mindray DS USA Inc. issued a Medical Device Service Notice dated March 9, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Customers requiring technical assistance were instructed to contact Mindray's Technical Support team at 1-800-288-2121. Mindray will address the systems response to DST in a future software update which will be provided to the customer at no cost.
Quantity in Commerce 1447 units US, 45 units OUS
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 = MHX and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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