Recall Z-1675-2015 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. dba Mindray North America
Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients within a defined coverage area.
| Date | May 26, 2015 (initiated Mar 12, 2015) |
| Status | Terminated |
| Reason | Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is in use with Mindray Passport V Monitor. Arrhythmia alarms which were previously displayed on both the Passport V and Panorama will not be displayed on the Panorama following a restart of either system (due to communication loss, restart, etc.). |
| Root cause | Software design |
| Action | Mindray sent a Corrective Action letter dated March 12, 2015 to their affected customer via FedEx. The letter identified the affected product, problem and actions to be taken. For questions call 201-995-8407. |
| Quantity | 4 units |
| Distribution | Worldwide Distribution - US Nationwide in the state of TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142601 | Panorama Patient Monitoring Network Shenzhen Mindray Bio-Medical Electronics Co., Nov 14, 2014 |