FDA-Device2019-05-22Class II
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.
Terumo Cardiovascular Systems Corporation
Hazard
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
Sold states
Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and United Arab Emirates.
Affected count
1258
Manufactured in
6200 Jackson Rd, Ann Arbor, MI, United States
Products
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1337-2019Don't want to check this manually?
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