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.
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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