Natus Medical Incorporated, Olympic Cool-Cap System: Class I Recall
MedSun: Newsletter #80, January 2013

FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I Recall of the Olympic Cool-Cap System, because 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.

Additional Information:

FDA MedWatch Safety Alert. Natus Medical Incorporated, Olympic Cool-Cap System: Class I Recall. December 12, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm331853.htm


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