Mediana Co., Ltd.: Medical Device Recall in 2020 - (Recall #: Z-2441-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 15, 2020

Date Posted: July 8, 2020

Recall Number: Z-2441-2020

Event ID: 85685

Reason for Recall:

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

Status: Terminated

Product Quantity: 180 devices

Code Information:

Serial Numbers: 456802000001~456802000180

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated