FDA-Device2014-11-19Class II
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).
Maquet Cardiovascular Us Sales, Llc
Hazard
Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power
Sold states
Worldwide Distribution - US Nationwide
Affected count
331 units
Manufactured in
45 Barbour Pond Drive, Wayne, NJ, United States
Products
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0211-2015Don't want to check this manually?
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