Medivance Inc. is recalling approximately 10,507 Arctic Sun Temperature Management Systems due to a software issue where the device may fail to reach the target water temperature without alerting the user. This occurs while the device is in patient control mode and can be triggered by sudden patient temperature changes, water flow interruptions, or blocked air filters. A software update will be released to correct this defect and ensure alarms function properly when the device cannot maintain the correct temperature. These systems are used in hospitals and medical facilities worldwide to control patient body temperature.
If the system fails to reach the target temperature and the alarm does not sound, medical staff may not be aware of the malfunction, potentially leading to the patient becoming dangerously cold (hypothermia) or overheated (hyperthermia).
You have 2 options:
Software update to correct the alarm notification failure.
Healthcare provider notification.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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