Recall Z-1843-2012— Natus Medical Incorporated

Class II FDA medical device recall by Natus Medical Incorporated, initiated 2012-05-21, terminated 2014-02-21. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..

Recalling firm

Natus Medical Incorporated

Classification

Class II

Status

Terminated

Initiated

2012-05-21

Terminated

2014-02-21

Firm location

Seattle, WA, United States

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