Recall Z-1575-2016 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. dba Mindray North America
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.
| Date | Mar 9, 2016 |
| Status | Terminated |
| 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. |
| Root cause | 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 | 1447 units US, 45 units OUS |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150882 | Edwards Suture Fastening System Edwards Lifesciences, LLC, Jun 16, 2015 |