FDA-Device2019-06-19Class II
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
Terumo Cardiovascular Systems Corporation
Hazard
An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can only be controlled by the local control knobs.
Sold states
Distribution US nationwide, including CA, CT, IL, IN, KY, MI, MN, MO, MT, NM, NY, OH, and WI. Foreign distribution to Canada, Mexico, and South Korea.
Affected count
72
Manufactured in
6200 Jackson Rd, N/A, Ann Arbor, MI, United States
Products
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1769-2019Don't want to check this manually?
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