Potential Leak Onto Control Board Gets Hamilton Ventilator Recall Deemed Class I
The FDA has deemed Hamilton Medical’s recall of certain of its ventilators as class I, the most serious type of recall, as a potential leak could cause the machine to stop delivering air, which could lead to serious injury or death.
The firm initiated the recall on July 26, citing the potential for capacitators to leak electrolyte fluid onto the ventilator’s control board. “If the control board contacts the electrolyte fluid, the control board or installed spare parts could short circuit,” the FDA said, switch to “Ambient State” and stop delivering air to the patient.
The recall is considered a correction because the ventilator should be serviced, the FDA said, and then can be returned to use.
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