FDA Recall
Terminated
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: Z-2441-2020
·
Initiated May 15, 2020
Recall
- Recall Number
- Z-2441-2020
- Event Number
- 85685
- Firm
- Mediana Co., Ltd. 132 Donghwagongdan-Ro Munmag-Eup Wonju Korea (the Republic of)
- FEI Number
- 3003591740
- Product Code
- DXN
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- May 15, 2020
- Terminated
- September 16, 2022
Description
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.
Reason
Failures were found in the temperature measurement function while in the predict mode.
Action
The firm notified their sole consignee on 05/15/2020 by email. The device is being recalled to the user level.
Distribution
US Nationwide distribution.
Quantity
180 devices