If it’s not one thing, it’s another. Weeks after the FDA handed down a Class I label to Hamilton Medical’s recall of its ventilators caused by a software conflict, the company has now received a second focused on a hardware problem.
The previous Class I rating, the agency’s most serious, was applied in late July to a recall that spanned more than 21,000 of Hamilton’s C1, C2, C3 and T1 ventilators distributed over the course of a decade and used to assist the breathing of patients ranging from neonates to adults.
The company had received at least 80 reports that a software glitch could cause some ventilators to switch to an “Ambient State,” stopping air flow unexpectedly. That issue specifically occurred in machines that had been used for at least three months without restarting.
Around the same time, Hamilton had notified healthcare providers in late July of the possibility of a short circuit within the ventilators’ control hardware. According to the manufacturer, degrading capacitors could leak material and fry parts of the circuit board, potentially leading to interruptions in ventilation.
This recall affected a smaller number of Hamilton’s C1 and T1 ventilators compared to the software issue but also included the company’s MR1 machines, which are designed to be used in intensive care and MRI suites. The recall also covered sets of spare replacement parts, for a total of less than 1,500 units.
Hamilton has urged healthcare providers to inspect their devices and contact local distributors to get affected machines serviced with high priority.
This year, the agency has doled out more than half a dozen Class I ratings to recalls of breathing support machines made by a variety of medtech manufacturers. Dräger received the FDA’s top recall label over possible contaminants in pediatric ventilators in August, for the German company’s fourth of the year.
Meanwhile, Philips reached its first settlement stemming from its yearslong recall of home CPAP and BiPAP machines, starting with at least $479 million to cover economic loss claims—that is, for users who had to pay to get their ventilators replaced or repaired.
Philips reported this summer that it has produced around 99% of the repair kits and replacement devices needed to cover its massive respiratory hardware recall, which, since spring 2021, has ballooned to about 5.5 million devices around the world.
However, in mid-August, the medtech giant received yet another Class I label for a recall of more than 120,000 of its Trilogy hospital ventilators after discovering that dust and dirt had gotten into the air paths of some devices.