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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.

FDA Recall Z-1675-2015 · Posted 2015-05-26

Recalling FirmMindray DS USA, Inc. dba Mindray North America
Recall StatusTerminated
Product CodeMHX
Date Initiated2015-03-12
Date Terminated2017-03-28
Product Quantity4 units

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.).

Firm Action

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.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - US Nationwide in the state of TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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