Recall Z-0845-2014
Philips Healthcare · initiated January 13, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Model Numbers: 861470 (120V), 861472 (240V).
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Philips Healthcare Recall Notice for this proactive performance correction was provided verbally to hospital biomedical engineers. Philips product support engineering scheduled and conducted the update on customer devices to the most current MCB configuration.
Details
- Recall number
- Z-0845-2014
- Initiated
- January 13, 2014
- Posted by FDA
- January 27, 2014
- Terminated
- February 13, 2014
- Product code
- NCX – System, Hypothermia, Intravenous, Cooling
- Quantity
- 50
- Distribution
- Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherlands, Spain, Sweden, and Switzerland.
- Recalling firm
- Philips Healthcare, San Diego, CA