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 Initiated
- December 15, 2015
- Posted
- January 29, 2016
- Terminated
- March 29, 2017
- Recall Number
- Z-0701-2016
- Quantity
- 63 products
- Firm Location
- Mahwah, NJ
Reason for Recall
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.
Distribution
Nationwide Distribution.
Lot / Code Info
version 11.5.1
Root Cause
Software design
Action Taken
The firm, Mindray DS USA, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 12/15/2015 to its customers via certified mail. The letter described the product, problem, and actions to be taken. The customers were instructed to route the recall letter to all potential users of your facility. Mindray will resolve the issue by upgrading the system software on all affected Panorama systems in your facility. Please contact your Mindray Service Representative at 1-800-288-2121 (Monday-Friday 8:30am-5:30pm) to arrange upgrade. If you have any questions, please contact Director, Quality Operations and Regulatory Affair at 201-995-8407 or email to: d.arpino@mindray.com.