Recall Z-0845-2014 ยท NCX System, Hypothermia, Intravenous, Cooling
Philips Healthcare
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
| Date | Jan 27, 2014 (initiated Jan 13, 2014) |
| Status | Terminated |
| Reason | Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 50 |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherlands, Spain, Sweden, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080908 | INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM Innercool Therapies, Inc.- A Delaware Corporation, Oct 17, 2008 |