PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: June 3, 2015 Initiated: March 12, 2015 #Z-1675-2015

Product Description

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.

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.).

Details

Units Affected
4 units
Distribution
Worldwide Distribution - US Nationwide in the state of TX.
Location
Mahwah, NJ

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Mindray DS USA, Inc. dba Mindray North America. Units affected: 4 units.
Why was this product recalled? ▼
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.).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 3, 2015. Severity: Moderate. Recall number: Z-1675-2015.

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