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Maquet Cardiovascular Us Sales, Llc recalls Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thoroug
Recalled November 19, 2014 · FDA recall Z-0211-2015 · Maquet Cardiovascular Us Sales
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 · FDA Class II
Units
331 units
Sold at
Worldwide Distribution - US Nationwide
Description
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
Product
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).
Manufacturer(s)
Maquet Cardiovascular Us Sales, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →