FDAFDA · Food and drugs·Recall number Z-0845-2014
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
Published February 5, 2014 · Recall initiated: January 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Philips Healthcare
- Distributor
- Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherlands, Spain, Sweden, and Switzerland.
- Lot
- Model Numbers: 861470 (120V), 861472 (240V).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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