FDAJune 8, 2021device
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Official recall recorded by the U.S. Food & Drug Administration.
The 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
What to do
FDA enforcement status: Terminated
Brands named
terumo cardiovascular systemsterumoterumo cardiovascular
UPCs
00886799000588
Recall history
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