Mindray Panorama Patient Monitoring Network Cl II

Company: Mindray DS USA, Inc. dba Mindray North America
Date of Enforcement Report 5/4/2016
Class lI:

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.. Recall Number Z-1575-2016

REASON
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.

RECALLING FIRM/MANUFACTURER
Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ on 3/9/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1447 units US, 45 units OUS

DISTRIBUTION
Nationwide

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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