FDA-Device2021-09-01Class II
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Terumo Cardiovascular Systems Corporation
Hazard
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
Sold states
International distribution in the country of Panama.
Affected count
1 unit OUS
Manufactured in
6200 Jackson Rd, N/A, Ann Arbor, MI, United States
Products
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2350-2021Don't want to check this manually?
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