Avanos Medical is recalling 24 units of its COOLIEF RF Generator, an 80-watt medical device used for radio-frequency lesioning procedures. The recall was initiated because the manufacturer received an increase in reports of the devices displaying F100 and F101 system faults. These technical errors can interrupt medical procedures and may prevent the device from operating as intended during patient treatment.
The F100 and F101 faults represent system errors that can cause the generator to malfunction or stop working during a procedure. This may lead to treatment delays or incomplete medical procedures for patients undergoing radio-frequency therapy.
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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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