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U.S. Department of Health and Human Services

Class 2 Device Recall Thermal Regulating System

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  Class 2 Device Recall Thermal Regulating System see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = NCX and Original Applicant = INNERCOOL THERAPIES, INC.- A DELAWARE CORPORATION
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