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

Recall date

May 17, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2096-2021

FDA classification

Class II

Brand / firm

Mediana Co., Ltd.

Sold / distributed

US Distribution to: Wisconsin only

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.