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FDAFDA · Food and drugs·Recall number Z-2441-2020

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.

Published July 8, 2020 · Recall initiated: May 15, 2020

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Mediana Co., Ltd.
Distributor
US Nationwide distribution.
Lot
Serial Numbers: 456802000001~456802000180
Risk classification
Class II
Area (FDA)
device
Country
Korea (the Republic of)

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