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MC3 Nautilus(tm) Smart Power Supply 12VDC
MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Model 48150 · UDI-DI 10850007732032
BYS
Prescription
3
510(k) clearances
177
Adverse events (5 deaths)
2
Recalls
7
Facilities
Description
12V power supply component for the Nautilus(tm) Smart ECMO Module
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-11 | Mc3 Inc | May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange |
| 2023-10-11 | Mc3 Inc | May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.