Mediana Co., Ltd.: Medical Device Recall in 2021 - (Recall #: Z-2096-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 17, 2021

Date Posted: July 28, 2021

Recall Number: Z-2096-2021

Event ID: 88166

Reason for Recall:

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

Status: Terminated

Product Quantity: 618

Code Information:

Serial #(s) 460062000002 thru 460062000501 and 460062100033 thru 460062100150 UDI:(01)18800003460066

Distribution Pattern:

US Distribution to: Wisconsin only

Voluntary or Mandated:

Voluntary: Firm initiated