RecallDepth

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.

Company
Mindray Ds Usa, Inc. D.B.A. Mindray North America
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

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.

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