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Z-2457-2024 Class II Ongoing

Recalled by Medivance Inc. — Louisville, CO

FDA device recall Z-2457-2024 was initiated by Medivance Inc. on June 27, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 10507.

Recall Details

Product Type: Devices
Report Date: August 7, 2024
Initiation Date: June 27, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10507

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

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.

Distribution Pattern

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

Code Information

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.