Maquet Medical Systems USA recalls CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
- Recall date
- April 15, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1831-2024
- FDA classification
- Class II
- Brand / firm
- Maquet Medical Systems USA
- Sold / distributed
- US Nationwide distribution in the states of NJ & TX.
Why it was recalled
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
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