Recall Z-2096-2021— Mediana Co., Ltd.

Name: FDA recall Z-2096-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-17

Class II · Terminated

Class II FDA medical device recall by Mediana Co., Ltd., initiated 2021-05-17, terminated 2022-11-04. It names one FDA 510(k) clearance: K200434. Product: AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used 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: In some cases the equipment fails to power up and/or key or button unresponsive or not working..

Recalling firm: Mediana Co., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2021-05-17
Terminated: 2022-11-04
Firm location: Wonju, N/A, Korea (the Republic of)

510(k) clearances named in this recall

1 on FDA's record

K200434 — V20, V20a, AVSM3 SNFMediana Co., Ltd.·cleared 2020-10-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used 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 for recall

In some cases the equipment fails to power up and/or key or button unresponsive or not working.

Data sourced from openFDA. This site is unofficial and independent of the FDA.