Maquet Medical Systems USA: 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

Hazard

CARDIOHELP-i System was not properly tested to measure leakage current

Details from the source

Reason for recall: CARDIOHELP-i System was not properly tested to measure leakage current Distribution: Nationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iran, Islamic Republic Of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, K Quantity: 1594 units Lot/code info: UDI-DI: 04058863074863; 04037691658384 All serial numbers up to and including 90415172

UPC codes

04058863074863, 04037691658384

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.