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U.S. Department of Health and Human Services

Class 2 Device Recall Mindray DS USA, Inc. Panorama Patient Monitoring Network

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 Class 2 Device Recall Mindray DS USA, Inc. Panorama Patient Monitoring Networksee related information
Date Initiated by FirmJanuary 08, 2014
Date PostedMarch 07, 2014
Recall Status1 Terminated 3 on January 21, 2015
Recall NumberZ-1156-2014
Recall Event ID 67495
510(K)NumberK031760 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductPanaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.
Code Information p/n 0998-00-0708-01; 0998-UC-0708-01 and 0020-00-0205-XXX
FEI Number 2221819
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		Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindrays V-Series Monitor. Additionally, event indicators lag behind the Panorama system time clock when the Panorama Central Station is in use with a Panorama Telepack.
FDA Determined
Cause 2		Software design
ActionMindray DS USA Inc. sent an Urgent Corrective Action letter dated January 8, 2014 via certified mail to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact Mindray Service Representative, at 1-800-288-2121 (Monday  Friday 8:30 am-5:30 pm), to arrange for the software update of the Panorama System(s) in their facility. This work will be performed at no cost.
Quantity in Commerce732 units in the US
DistributionWorldwide Distribution - USA Nationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MHX
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