FDA recall Z-2441-2020

Product

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.

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2020-05-15

Report date

2020-07-08

Termination date

2022-09-16

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-2441-2020