FDA recall Z-2350-2021

Product

Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

Reason for recall

intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

Distribution

International distribution in the country of Panama.

Key facts

Status

Terminated

Initiation date

2021-06-08

Report date

2021-09-01

Termination date

2022-06-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ann Arbor, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2350-2021