Device Recall Thermal Regulating System

Model Numbers: 861470 (120V), 861472 (240V).

Neurological Devices

2

No

Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherlands, Spain, Sweden, and Switzerland.

InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). || Product Usage: || The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. || K080908