Recall Z-2441-2020— Mediana Co., Ltd.

Name: FDA recall Z-2441-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-15

Class II · Terminated

Class II FDA medical device recall by Mediana Co., Ltd., initiated 2020-05-15, terminated 2022-09-16. It names one FDA 510(k) clearance: K170497. 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.. Reason: Failures were found in the temperature measurement function while in the predict mode..

Recalling firm: Mediana Co., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2020-05-15
Terminated: 2022-09-16
Firm location: Wonju, N/A, Korea (the Republic of)

510(k) clearances named in this recall

1 on FDA's record

K170497 — V10Mediana Co., Ltd.·cleared 2017-12-15

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

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 for recall

Failures were found in the temperature measurement function while in the predict mode.

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