Medical Device Recall: Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic S
Medivance Inc. · June 27, 2024
Reason for Recall
If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air flow by an obstruction or dirty filter, then system may not alert, and alarm absence may lead to hypothermia or hyperthermia, so a software update will be released to correct issue.
Product Description
Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E; Loaner, Arctic Sun M5000, NA/5000-00-00L; Arctic Sun 5000, EU/5000-1-01; Loaner, Arctic Sun M5000, EU/5000-01-01L; Arctic Sun 5000, UK/5000-01-02; Arctic Sun 5000, Australia/5000-01-03; Arctic Sun 5000, China/5000-01-04; Arctic Sun 5000, Brazil/5000-01-05; Arctic Sun 5000, Switzerland/5000-01-07; Arctic Sun 5000, South Africa/5000-01-08
Distribution
Worldwide - US Nationwide distribution including in the states of IN, OK, MO, FL, CT, KS, TX, NJ, CA, OR, HI, IL, WI, VA, KY, NH, CO, NV, LA, NC, ID, UT, GA, SC, TN, MD, PA, IA, MA, OH, NY, DE, MI, NM, WV, AZ, DC, VT, MN, SD, AL, AR, WA, NE, ND, MT, AK, MS, ME, WY, RI, PR, OK, OR and the countries of CA, DE, AT, BE, FI, TR, NO, DK, JP, ES, AU, FR, GB, IT, SE, PT, AE, SA, ZA, RU, KR, CY, TH, GR, TW, MY, OM, CN, SG, GI, NL, IL, CZ, RO, CH, RE, PL, PE, SK, AR, IN, CL, MX, QA, BR, SI, HU, JO, LU, KW, PH, NZ, HK, VN, IR, BN, UA, ID, CO, KZ, HR, IS, GU, GE, BH, EE, AM, PA, KR, CL, TH, MY, JP, AU, BD, BE, TW
States Affected
NATIONWIDE
Quantity Affected
10507
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2457-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.