Arctic Sun Temperature Management Systems — Class II medical device recall Z-2457-2024
Ongoing recall by Medivance Inc., reported 2024-08-07, distributed nationwide. If temperature management system fails to reach correct target water temperature while device is operating in
| Recall number | Z-2457-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medivance Inc., Louisville, CO, United States |
| Recall initiated | 2024-06-27 |
| Classified | 2024-07-31 |
| Reported by FDA | 2024-08-07 |
| Distributed | Nationwide (US) |
| Quantity | 10,507 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00801741080142, 00801741080159, 00801741127755, 00801741144653, 00801741161513, 00801741161520, 00801741170003, 00801741186134, 00801741186141, 00801741222818, 00801741222825, 00801741222832, 00801741222849, 00801741226380, 00801741226397, 00801741226403 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2457-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.