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U.S. Department of Health and Human Services

Class 2 Device Recall hypo/hyperthermia system

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 Class 2 Device Recall hypo/hyperthermia systemsee related information
Date Initiated by FirmJanuary 05, 2005
Date PostedJanuary 26, 2005
Recall Status1 Terminated 3 on March 25, 2005
Recall NumberZ-0436-05
Recall Event ID 30896
510(K)NumberK002577 K010338 
Product Classification System, Thermal Regulating - Product Code DWJ
ProductArctic Sun Temperature Management System
Code Information Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt) Serial numbers 3001 thru 3080
FEI Number 3003329224
Recalling Firm/
Manufacturer		 MEDIVANCE INC.
1172 W Century Dr Ste 240
Louisville CO 80027-1681
For Additional Information Contact
303-926-1917
Manufacturer Reason
for Recall		Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.
FDA Determined
Cause 2		Other
ActionUS customers were notified by telephone on 1/5-6/2005, followed by letter confirmation.
Quantity in Commerce67 units
DistributionAL, AZ, CO, DC, FL, GA, IA, IN, KS, MA, MD, MI, MO, NC, NY, OH, PA, TX, VA, WA. No government or military distribution. Foreign distribution to Austria, Belgium, Canada, Germany, Japan, Netherlands, Norway, Scotland.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DWJ
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