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Mindray DS USA, Inc. dba Mindray North America recalls Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number
Recalled June 3, 2015 · FDA recall Z-1675-2015 · Mindray DS USA, Inc.
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.). · FDA Class II
Units
4 units
Sold at
Worldwide Distribution - US Nationwide in the state of TX.
Description
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.).
Product
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.
Manufacturer(s)
Mindray DS USA, Inc. dba Mindray North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →