Belmont Instrument LLC is recalling 229 units of the Allon 2001 system, used with ThermoWrap patient wraps, because the device can overheat without notifying medical staff. An investigation revealed that if internal sensor boards are disconnected and alarms are disabled, the system can heat water above safe limits. One incident of the device exceeding its set temperature has been reported, though no injuries have been documented to date.
If the device's internal human sensor board or water sensors are disconnected while alarms are turned off, the system will continue to heat water beyond safe hardware limits without warning the user. This poses a significant risk of thermal burns or other heat-related injuries to patients undergoing treatment.
Recall #: Z-1966-2025
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.
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Sources: FDA iRES · Raw API Response
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