Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System: Blood oxygenation an
Recalled Product
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012
Hazard / Issue
CARDIOHELP-i System was not properly tested to measure leakage current
Issued by
FDA
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