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.
This recall has been terminated (originally issued May 26, 2015).
- Recall Initiated
- March 12, 2015
- Posted
- May 26, 2015
- Terminated
- March 28, 2017
- Recall Number
- Z-1675-2015
- Quantity
- 4 units
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.).
Distribution
Worldwide Distribution - US Nationwide in the state of TX.
Lot / Code Info
Part No: 0998-00-0708-01 Software version 8.9
Root Cause
Software design
Action Taken
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.