Mindray DS USA, Inc. dba Mindray North America recalls Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work St…

Recall date

December 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0701-2016

FDA classification

Class II

Brand / firm

Mindray DS USA, Inc. dba Mindray North America

Sold / distributed

Nationwide Distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.