FDA Enforcement
Class II
Terminated
Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Panaroma Patient Monitoring Network is intended for use in a fixed location in the healthcare facility setting as a central viewing station. It is not intended to be directly connected to patient at any time or installed in a patient's vicinity.
Recall: Z-0701-2016
·
Reported February 10, 2016
Enforcement
- Recall Number
- Z-0701-2016
- Event ID
- 72864
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Mindray DS USA, Inc. dba Mindray North America
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 10, 2016
- Initiation Date
- December 15, 2015
- Classification Date
- January 29, 2016
- Termination Date
- March 29, 2017
- Address
- 800 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2001, United States
Description
Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Panaroma Patient Monitoring Network is intended for use in a fixed location in the healthcare facility setting as a central viewing station. It is not intended to be directly connected to patient at any time or installed in a patient's vicinity.
Reason
An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation. On restart, monitoring will be lost for about 2.5 minutes. Settings and configurations are maintained.
Code Info
version 11.5.1
Distribution
Nationwide Distribution.
Quantity
63 products