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Recall Observatory FDA recall evidence

Device 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.

Z-1675-2015

March 12, 2015

Class II

Product summary

Firm
Mindray DS USA, Inc. dba Mindray North America
Event
Event 70959
Status
Terminated
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-1675-2015

Official wording

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.).

Code information: Part No: 0998-00-0708-01 Software version 8.9

Distribution pattern: Worldwide Distribution - US Nationwide in the state of TX.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software anomaly