FDAMarch 12, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.).
What to do
FDA enforcement status: Terminated
Brands named
mindray ds usa inc dba mindray north americamindraymindray ds
UPCs
099800070801
Recall history
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