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.
Enforcement
- Recall Number
- Z-1675-2015
- Event ID
- 70959
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Mindray DS USA, Inc. dba Mindray North America
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- June 3, 2015
- Initiation Date
- March 12, 2015
- Classification Date
- May 26, 2015
- Termination Date
- March 28, 2017
- Address
- 800 MacArthur Blvd, Mahwah, NJ, 07430-2001, United States
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.
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.).
Part No: 0998-00-0708-01 Software version 8.9
Worldwide Distribution - US Nationwide in the state of TX.
4 units