The Recall Desk
HighFDA (Devices)·Z-1675-2015·Announced 2015-06-03

Mindray Recalls Panorama Patient Monitoring Network Due to Software Anomaly

Mindray is recalling four Panorama Patient Monitoring Network units due to a software anomaly that prevents arrhythmia alarms from displaying on the Panorama system after a restart.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a failure to display critical arrhythmia alarms in a medical device, which poses a risk of harm to patients even though no specific injuries are reported in the source text.

Plain-English summary

Mindray DS USA, Inc. dba Mindray North America is recalling four units of the Panorama Patient Monitoring Network, Multi-Parameter Patient Monitor (Part number 0998-00-0708-01, Software version 8.9). The recall is due to a software anomaly that occurs when the Panorama system is used with the Mindray Passport V Monitor.

The specific issue involves arrhythmia alarms that were previously displayed on both the Passport V and Panorama systems. Following a restart of either system—whether due to communication loss or other reasons—these alarms will no longer be displayed on the Panorama system. This defect affects the ability of the Panorama system to display specific alarm information after a system restart.

The affected units were distributed worldwide and nationwide in the United States, specifically within the state of Texas. Healthcare facilities and users of this equipment should contact Mindray for instructions on how to resolve the software issue.

The recalled product

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 withi
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part No: 0998-00-0708-01 Software version 8.9

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: