Medivance recalls Arctic Sun STAT temperature management systems that may fail to alert during patient use, risking hypothermia or hyperthermia. Software update available to fix issue.
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.
Medivance is recalling Arctic Sun STAT temperature management systems that could fail to alert patients if water temperature isn't maintained properly, potentially causing hypothermia or hyperthermia. A software update will correct this issue.
If the system fails to reach the correct water temperature during patient use due to sudden temperature changes, water flow interruptions, or blocked air flow, it may not alert. This could lead to hypothermia or hyperthermia if the patient's condition changes.
Patients using Arctic Sun STAT temperature management systems for medical purposes are most at risk. The recall applies to specific models sold globally.
Check for model names like Arctic Sun STAT, Arctic Sun STAT Loaner, Arctic Sun 5000, or specific serial numbers with software versions 1.0.5 or earlier. The recall covers units sold in North America, Europe, Asia, and other regions.
Verify your device's software version; if it's 1.0.5 or earlier, it's affected.
Download and install the latest software update to fix the temperature alert issue.
No, you can continue using it after installing the software update.
Software versions 1.0.5 and earlier for Arctic Sun STAT models, and 2.1.1.0 and earlier for Arctic Sun 5000 models.
Yes, the recall covers units sold in North America, Europe, Asia, and other regions with specific model numbers.
We’ve drafted a message you can send Medivance to request your refund or repair — edit it as you like.
Subject: Recall Z-2457-2024 — Medivance Medivance Hello, I own a Medivance that is covered by recall Z-2457-2024 from Medivance. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
