Olympic Cool-Cap System is intended to provide treatment for neonatal… — Class II medical device recall Z-1843-2012
Terminated recall by Natus Medical Incorporated, reported 2012-06-27, distributed nationwide. Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure can happen wi
| Recall number | Z-1843-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Medical Incorporated, Seattle, WA, United States |
| Recall initiated | 2012-05-21 |
| Classified | 2012-06-20 |
| Reported by FDA | 2012-06-27 |
| Terminated | 2014-02-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, CA, DE, EG, ES, GB, HK, ID, IR, IT, KR, KW, PL, RU, SA, SG, SI, TH, TR, TW, ZA |
| Quantity | 181 units |
| Serial numbers | 1008, 1009, 1011, 1012, 1014, 1016, 1017, 1018, 1020, 1021, 1022, 1023, 1024, 1025, 1027, 1028, 1030, 1031, 1034, 1035, 1036, 1038, 1044, 1045, 1048 and 156 more |
Product
Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in part: "***OLYMPIC COOL-CAP Cooling Unit***Model No.***Made in USA***Software in this product is Natus Medical Incorporated***"
Reason for recall
Olympic 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 system to begin or continue cooling treatment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1843-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.