Reported Feb 5, 2014 · Terminated

InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device…

Philips Healthcare

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Healthcare · 6740 Top Gun St · San Diego, CA · 92121-4114

Is this the product you have?

  • InnerCool RTx Endovascular System
  • Model Numbers
    • 861470 (120V)
    • 861472 (240V)
  • Product UsageThe 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
Lot codes and dates
  • Model Numbers
    • 861470 (120V)
    • 861472 (240V)
Amount recalled
50

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 13, 2014 · Data as of Sep 19, 6:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.