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Terumo Cardiovascular Systems Corporation recalls Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI
Recalled June 19, 2019 · FDA recall Z-1769-2019 · Terumo Cardiovascular Systems
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. · FDA Class II
Units
72
Sold at
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.
Description
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.
Product
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →