Skip to content
Recall Observatory FDA recall evidence

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

January 13, 2014

Class II

Product summary

Firm
Philips Healthcare
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

    reason.no_named_rule · v1.0.0

    Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.