Respironics, a division of Philips Healthcare ($PHG), recalled many of its Trilogy ventilators in April, and the FDA responded with a Class I label in turn.
The problem: faulty power supply components that can lead the ventilators to shut down without warning. The devices' alarms can also fail when the power goes out, and the interruption in ventilation could lead to severe health effects and death, according to the FDA. Class I is the agency's most serious designation, used only when there is significant risk of injury or death.
On April 27, Respironics reached out to customers and instructed them to quarantine affected device, which the company will replace. The company said it didn't receive reports of ventilator failure from patients. The affected techs are the Trilogy 100, 200 and 202, according to the FDA, devices used at home and in hospitals to provide breathing assistance to pediatric and adult patients.
Respironics reclaimed all affected Trilogy 202 models and will get ahold of the rest of the recalled devices, the company said.
Philips bought Respironics for $5.2 billion back in 2008. The company produces devices to help patients breathe, sleep and take respiratory therapies.
- read the FDA's recall notice