Official recall record
Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-06-27
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00801741161513
- Brand on record
- Medivance Inc.
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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