Recall Z-0447-2013— Natus Medical Incorporated

Class I FDA medical device recall by Natus Medical Incorporated, initiated 2012-05-09, terminated 2015-01-27. FDA's recall record names no specific 510(k) clearance for this event. 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: 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

Natus Medical Incorporated

Classification

Class I

Status

Terminated

Initiated

2012-05-09

Terminated

2015-01-27

Firm location

Seattle, WA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.