FDAFDA · Food and drugs·Recall number Z-2457-2024
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
Published August 7, 2024 · Recall initiated: June 27, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medivance Inc.
- Distributor
- 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
- Lot
- REF/UDI-DI/Software: 6000-00-00/00801741161513/v1.0.5 and prior, 6000-00-00L/00801741161520/v1.0.5 and prior, 600001/00801741226380/v2.1.1.0 and prior, 600006/00801741226397/v2.1.1.0 and prior, 600020/00801741226403/v2.1.1.0 and prior, 5000-00-00/00801741080142/v3.0.2 and prior, 5000-00-00E/00801741127755/v3.0.2 and prior, 5000-00-00L/00801741080159/v3.0.2 and prior, 5000-1-01/00801741186134/v3.0.2 and prior, 5000-01-01L/00801741186141/v3.0.2 and prior, 5000-01-02/00801741170003/v3.0.2 and prior, 5000-01-03/00801741222818/v3.0.2 and prior, 5000-01-04/00801741144653/v4.0.0 and prior, 5000-01-05/00801741222825/v3.0.2 and prior, 5000-01-07/00801741222832/v3.0.2 and prior, 5000-01-08/00801741222849/v3.0.2 and prior All serial numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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