The product has the Catalogue/Part number 60010 — Class I medical device recall Z-0447-2013
Terminated recall by Natus Medical Incorporated, reported 2012-12-12, distributed nationwide. The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-scr
| Recall number | Z-0447-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Medical Incorporated, Seattle, WA, United States |
| Recall initiated | 2012-05-09 |
| Classified | 2012-11-30 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2015-01-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BH, CA, CL, CN, CO, DE, EC, EG, ES, GB, HK, ID, IN, IQ, IR, IT, KR, KW, LV, MA, MX, MY, PA, PL, QA, RO, RU, SA, SG, SI, TH, TR, TW, UA, VE, VN, ZA |
| Quantity | 324 units |
| Model numbers | 60010 |
Product
The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of 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 parts: "***OLYMPIC COOL-CAP Cooling Unit***Natus Medical Incorporated 5900 First Avenue South ***Made in USA***Control Unit Model No. 60010***Software in this product is***Technical Service***"
Reason for recall
The 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 providing cooling treatment to the infants. The visible clock displayed at the upper right hand corner of the screen stops advancing.
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-0447-2013. 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.