Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DIRECT SUPPLY Attendant VITAL SIGNS MONITOR Recalled by Mediana Co., Ltd. Due to Failures were found in the temperature measurement function...

Date: May 15, 2020
Company: Mediana Co., Ltd.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mediana Co., Ltd. directly.

Affected Products

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.

Quantity: 180 devices

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mediana Co., Ltd.

Mediana Co., Ltd. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report