Philips Healthcare: Medical Device Recall in 2014 - (Recall #: Z-0845-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 13, 2014

Date Posted: February 5, 2014

Recall Number: Z-0845-2014

Event ID: 67319

Reason for Recall:

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

Status: Terminated

Product Quantity: 50

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.

Voluntary or Mandated:

Voluntary: Firm initiated