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U.S. Department of Health and Human Services

Class 2 Device Recall Panorama Patient Monitoring System

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  Class 2 Device Recall Panorama Patient Monitoring System see related information
Date Initiated by Firm December 15, 2015
Date Posted January 29, 2016
Recall Status1 Terminated 3 on March 29, 2017
Recall Number Z-0701-2016
Recall Event ID 72864
510(K)Number K150082  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Panorama Patient Monitoring Network.
Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910.
The Panaroma Patient Monitoring Network is intended for use in a fixed location in the healthcare facility setting as a central viewing station. It is not intended to be directly connected to patient at any time or installed in a patient's vicinity.
Code Information version 11.5.1
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 Macarthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact
800-288-2121
Manufacturer Reason
for Recall		 An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation. On restart, monitoring will be lost for about 2.5 minutes. Settings and configurations are maintained.
FDA Determined
Cause 2		 Software design
Action The firm, Mindray DS USA, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 12/15/2015 to its customers via certified mail. The letter described the product, problem, and actions to be taken. The customers were instructed to route the recall letter to all potential users of your facility. Mindray will resolve the issue by upgrading the system software on all affected Panorama systems in your facility. Please contact your Mindray Service Representative at 1-800-288-2121 (Monday-Friday 8:30am-5:30pm) to arrange upgrade. If you have any questions, please contact Director, Quality Operations and Regulatory Affair at 201-995-8407 or email to: d.arpino@mindray.com.
Quantity in Commerce 63 products
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 = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
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