Maquet Medical Systems USA: CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory a

Hazard

Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp

Details from the source

Reason for recall: Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Brazil, Brunei, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, I Quantity: 1595 units Lot/code info: UDI Code: 04058863074863 (CARDIOHELP-I US); 04037691658384 (CARDIOHELP-I NONUS). All serial numbers up to and including 90415177.

UPC codes

04058863074863, 04037691658384

Source

Official record: FDA (Device enforcement) ↗

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