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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 Recall
Thermal Regulating System
see related information
Date Posted January 27, 2014
Recall Status1 Terminated on February 13, 2014
Recall Number Z-0845-2014
Recall Event ID 67319
Premarket Notification
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, California 92121-4114
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NCX and Original Applicant = INNERCOOL THERAPIES, INC.- A DELAWARE CORPORATION
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