Mediana Co., Ltd. 132 Donghwagongdan-Ro Munmag-Eup Wonju Korea (the Republic of) 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Mediana Co., Ltd. 132 Donghwagongdan-Ro Munmag-Eup Wonju Korea (the Republic of)
Lot Codes / Batch Numbers
Serial Numbers: 456802000001~456802000180
Products Sold
Serial Numbers: 456802000001~456802000180
Mediana Co., Ltd. 132 Donghwagongdan-Ro Munmag-Eup Wonju Korea (the Republic of) is recalling DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to due to Failures were found in the temperature measurement function while in the predict mode.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failures were found in the temperature measurement function while in the predict mode.
Recommended Action
Per FDA guidance
The firm notified their sole consignee on 05/15/2020 by email. The device is being recalled to the user level.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026