The FDA classified about 1,460 Hamilton Medical ventilators in a Class I recall, part of a voluntary correction, because electrolyte fluid might leak onto the device's control board.
A leakage could cause the ventilator to short-circuit and result in serious injury or death, the agency said Oct. 18. Hamilton Medical has not received any reports of adverse events related to the recall.
In late July, the company instructed customers to test the device's service software. The affected products include the Hamilton-C1 Portable Intensive Care Ventilator, Hamilton-T1 Intensive Care and Transport Ventilator, Hamilton-MR1 Intensive Care Ventilator, Hamilton C1/T1/MR1 Control Board Spare part and the Hamilton-T1 ESM Shielding Set Spare Part.
The recall is not a product removal.