Date Initiated by Firm | January 13, 2014 |
Date Posted | January 27, 2014 |
Recall Status1 |
Terminated 3 on February 13, 2014 |
Recall Number | Z-0845-2014 |
Recall Event ID |
67319 |
510(K)Number | K080908 |
Product Classification |
System, hypothermia, intravenous, cooling - Product Code NCX
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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 |
Code Information |
Model Numbers: 861470 (120V), 861472 (240V). |
Recalling Firm/ Manufacturer |
Philips Healthcare 6740 Top Gun St San Diego CA 92121-4114
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For Additional Information Contact | 858-677-6390 |
Manufacturer 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 2 | 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 in Commerce | 50 |
Distribution | Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherlands, Spain, Sweden, and Switzerland. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = NCX
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