FDA recall Z-2096-2021

Product

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.

Reason for recall

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

Distribution

US Distribution to: Wisconsin only

Key facts

Status

Terminated

Initiation date

2021-05-17

Report date

2021-07-28

Termination date

2022-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wonju, N/A, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2096-2021