Reported Sep 1, 2021 · Terminated
Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
Terumo Cardiovascular Systems Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Cardiovascular Systems Corporation · 6200 Jackson Rd · Ann Arbor, MI · 48103-9586
Is this the product you have?
- Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188
- Lot codes and dates
- S/N01751
- UDI00886799000588
- Amount recalled
- 1 unit OUS
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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