# FDA recall Z-2457-2024

> **Medivance Inc.** · Class II · device recall initiated 2024-06-27.

## Product

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

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

## Key facts

- **Recall number:** Z-2457-2024
- **Recalling firm:** Medivance Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-27
- **Report date:** 2024-08-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2457-2024

## Citation

> AI Analytics. FDA recall Z-2457-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2457-2024. Source: US FDA. Licensed CC0.

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