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Maquet Medical Systems USA recalls CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Recalled May 22, 2024 · FDA recall Z-1831-2024 · Maquet Medical Systems USA
Hazard
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels. · FDA Class II
Units
148 units (US: 5; OUS: 143)
Sold at
US Nationwide distribution in the states of NJ & TX.
Description
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Product
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Manufacturer(s)
Maquet Medical Systems USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →