FDA recall Z-1835-2020

Product

ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499

Reason for recall

Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter.

Distribution

US Nationwide Distribution in the states of FL, WI, NY, NC, VT, IL, MD, CA, NE, WA OUS: None

Key facts

Status

Terminated

Initiation date

2019-07-12

Report date

2020-05-06

Termination date

2023-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Clemente, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1835-2020