Company:Maquet Cardiovascular Us Sales, Llc.
Date of Enforcement Report 11/19/2014
Class lI:
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).
Recall Number Z-0211-2015
REASON
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
RECALLING FIRM/MANUFACTURER
Maquet Cardiovascular Us Sales, Llc, Wayne NJ on 10/17/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
331 units
DISTRIBUTION
Nationwide
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