Olympic Cool-Cap System Recall: Software Problems During Treatment

A medical head-cooling system for newborns is being recalled because of a software problem, which may cause it to fail while treating infants. 

The Olympic Cool-Cap System recall was announced by the FDA on December 12, impacting selective head cooling systems for full-term infants suffering from hypoxic-ischemic encephalopathy (HIE), which are manufactured by Natus Medical.

Natus originally sent out an Urgent: Medical Device letter to its customers in May, alerting them that the screen on the Control Module of the device can freeze. This means that despite information being shown on-screen that the caps are working, the infant may not be receiving cooling treatment.

This week the FDA determined that the letter constituted a Class I medical device recall, the highest designation a recall can receive. The Class I designation means that the FDA believes the cooling cap problem creates the reasonable probability that a patient will suffer severe injury or death. However, there have been no injuries or deaths reported in relation to the Olympic Cool-Cap problems.

The recall affects the Olympic Cool-Cap System, catalog/part number 60010, distributed between January 18, 2007 through April 20, 2012. The recall affects all serial numbers.

The caps are cooling water caps placed on the head of the infant while the body is warmed with radiant warmers. When working properly the caps provide 72 hours of monitored cooling for moderate to severe cases of HIE to prevent or reduce neurologic injury.

Customers with questions should contact Natus Technical Service at (888)496-2887.