FDA-Device2020-07-08Class II
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.
Mediana Co., Ltd.
Hazard
Failures were found in the temperature measurement function while in the predict mode.
Sold states
US Nationwide distribution.
Affected count
180 devices
Manufactured in
132 Donghwagongdan-Ro, Munmag-Eup, Wonju, N/A, Korea (the Republic of)
Products
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2441-2020Don't want to check this manually?
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