Recall Z-1156-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. dba Mindray North America
Panaroma 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.
| Date | Mar 7, 2014 (initiated Jan 8, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | Mindray 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 | 732 units in the US |
| Distribution | Worldwide Distribution - USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031760 | VIEWPOINT TELEMETRY SYSTEM Datascope Corp., Oct 10, 2003 |