Recall Z-1675-2015— Mindray DS USA, Inc. dba Mindray North America
Class II · Terminated
Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2015-03-12, terminated 2017-03-28. It names one FDA 510(k) clearance: K142601. 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.. 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.)..
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-12
- Terminated
- 2017-03-28
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.).
Data sourced from openFDA. This site is unofficial and independent of the FDA.