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Cool-Cap

NATUS MEDICAL INCORPORATED · Model 60026 · UDI-DI 00382830009577

MXM
0
510(k) clearances
61
Adverse events (2 deaths)
2
Recalls
0
Facilities

Description

COOLING CAP SET, MEDIUM SIZE, INT

Recalls

DateFirmReason
2012-05-21Natus Medical IncorporatedOlympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the syste
2012-05-09Natus Medical IncorporatedThe Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer provid

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Data 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.