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.
Reported: May 22, 2019 Initiated: April 18, 2019 #Z-1337-2019
Product Description
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.
Reason for Recall
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
Details
- Recalling Firm
- Terumo Cardiovascular Systems Corporation
- Units Affected
- 1258
- Distribution
- 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.
- Location
- Ann Arbor, MI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Terumo Cardiovascular Systems Corporation. Units affected: 1258.
Why was this product recalled? ▼
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2019. Severity: Moderate. Recall number: Z-1337-2019.
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