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Mediana Co., Ltd. recalls DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive
Recalled July 8, 2020 · FDA recall Z-2441-2020 · Mediana
Hazard
Failures were found in the temperature measurement function while in the predict mode. · FDA Class II
Units
180 devices
Sold at
US Nationwide distribution.
Description
Failures were found in the temperature measurement function while in the predict mode.
Product
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.
Manufacturer(s)
Mediana Co., Ltd.
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →