Company: Natus Medical Incorporated
Date of Enforcement Report 12/12/12
Class l:
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***”
Recall Number Z-0447-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
Natus Medical Incorporated, Seattle, WA on 5/9/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
324 units
DISTRIBUTION
Nationwide and Internationally
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