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)
- Model Numbers
- 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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