Device product
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
Z-0845-2014
Product summary
- Event
- Event 67319
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50
- Official record key
device-enforcement:Z-0845-2014
Official wording
Reason: Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.
Code information: Model Numbers: 861470 (120V), 861472 (240V).
Distribution pattern: Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherlands, Spain, Sweden, and Switzerland.
Derived failure modes
-
Unknown
Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.