MEDIVANCE INC. Arctic Sun Temperature Management System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Arctic Sun Temperature Management System
Brand
MEDIVANCE INC.
Lot Codes / Batch Numbers
Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt) Serial numbers 3001 thru 3080
Products Sold
Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt) Serial numbers 3001 thru 3080
MEDIVANCE INC. is recalling Arctic Sun Temperature Management System due to Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.
Recommended Action
Per FDA guidance
US customers were notified by telephone on 1/5-6/2005, followed by letter confirmation.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CO, FL, GA, IN, IA, KS, MD, MA, MI, MO, NY, NC, OH, OR, PA, TX, VA, WA, DC
Page updated: Jan 10, 2026