Mediana Co., Ltd. recalls DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive…

Recall date

May 15, 2020

Source

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

Recall number

Z-2441-2020

FDA classification

Class II

Brand / firm

Mediana Co., Ltd.

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

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

What was recalled

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.