FDA-Device2014-01-29Class II
Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor.
Medrad Mr Inc
Hazard
The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected shutdown of the system while in use, resulting in the loss of vital signs information from the monitor.
Sold states
Worldwide Distribution: US (nationwide) and Internationally to: Canada.
Affected count
922 units
Manufactured in
100 Global View Dr, Warrendale, PA, United States
Products
Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0810-2014Don't want to check this manually?
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