Mediana Co., Ltd. recalls AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), funct

Recalled July 28, 2021 · FDA recall Z-2096-2021 · Mediana

Hazard

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

Units

618

Sold at

US Distribution to: Wisconsin only

Description

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

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.

Manufacturer(s)

Mediana Co., Ltd.

Made in

Korea (the Republic of)

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →