Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
Reported: June 19, 2019 Initiated: October 17, 2018 #Z-1769-2019
Product Description
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
Reason for Recall
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.
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- 72
- Distribution
- 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.
- Location
- Ann Arbor, MI
Frequently Asked Questions
What product was recalled? ▼
Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 72.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 19, 2019. Severity: Moderate. Recall number: Z-1769-2019.
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