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Natus Medical Incorporated (BABY) Cooling Cap Hit With FDA Class I Recall


12/13/2012 9:00:35 AM

December 12, 2012 -- AUDIENCE: Risk Manager, OB/GYN, Pediatrics

ISSUE: FDA notified healthcare professionals of a Class I Recall of the Olympic Cool-Cap System, becasuse the device's Control Module may experience a frozen screen during treatment. When this occurs, the on-screen information remains on display, but the system is not providing cooling treatment to the infants.

All serial numbers are affected by this recall.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

BACKGROUND: The Olympic Cool Cap System (Cool-Cap) is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in full-term infants (at 36 weeks gestational age). 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 Cool-Cap is used with clinical evidence of moderate to severe HIE. The Cool-Cap provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE.

RECOMMENDATION: On May 16, 2012, Natus Medical Incorporated sent its customers an URGENT: MEDICAL DEVICE letter with an attached Field Safety Notice. The letter describes the product, problem, and the actions taken. Customers can call Natus Technical Service at 1-888-496-2887 for any questions about this recall.



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