Recall – Cardio-pulmonary bypass monitor display controls disabled

Company: Terumo Cardiovascular Systems Corporation
Date of Enforcement Report: 6/19/2019
Class II

PRODUCT

Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.

Recall Number: Z-1769-2019

REASON

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.

RECALLING FIRM/MANUFACTURER

Terumo Cardiovascular Systems Corporation on 6/19/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
72

DISTRIBUTION

US Nationwide and International

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