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.
FDA MedWatch Safety Alert. Natus Medical Incorporated, Olympic Cool-Cap System: Class I Recall. December 12, 2012.