Hamilton Medical is recalling some of its ventilators because of a problem with control boards on the devices that can interrupt treatment. The Food and Drug Administration designated the recall as Class I, its highest risk category, according to a Wednesday entry in the agency’s database.
Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte, causing the control board to short circuit or the capacitor to lose function. This can interrupt ventilation, according to the FDA notice.
The recall includes Hamilton’s T1 device, an ICU ventilator for transport; its MR-1 device, a ventilator that can be used during MRI scans; and its C1 device, a portable ventilator that can be used in the ICU, emergency room, step-down units and in transport between hospitals. It also includes a control board spare part for the three types of ventilators.
Hamilton sent an urgent medical device correction to customers on July 26, asking healthcare facilities to check for affected devices and contact local distribution partners to get the ventilators serviced with high priority.
Last month, Hamilton issued a separate recall of its C1, C2, C3 and T1 ventilators after learning they could switch to an “ambient state” if used in neonates for more than 91 days without a restart. At the time, the company said it was working on a software update for its C2 and C3 devices, and an update is already available for its C1 and T1 devices.