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Terumo Cardiovascular Systems Corporation recalls Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Recalled September 1, 2021 · FDA recall Z-2350-2021 · Terumo Cardiovascular Systems
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 · FDA Class II
Units
1 unit OUS
Sold at
International distribution in the country of Panama.
Description
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
Product
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →