Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
InnerCool RTx Endovascular System Recalled by Philips Healthcare Due to Phillips Healthcare initiated this action because the Main...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Healthcare directly.
Affected Products
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
Quantity: 50
Why Was This Recalled?
Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Healthcare
Philips Healthcare has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report