Recall Z-1575-2016— Mindray DS USA, Inc. dba Mindray North America
Class II · Terminated
Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2016-03-09, terminated 2018-04-19. It names one FDA 510(k) clearance: K150882. 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.. 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
- Mindray DS USA, Inc. dba Mindray North America
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-09
- Terminated
- 2018-04-19
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.