The FDA slapped Philips Healthcare (NYSE:PHG) subsidiary Respironics Inc. with a Class I recall for manufacturing issues in its ventilators that the agency says may result in patient injury or death.
Certain of the company’s Trilogy 100 ventilators may stop circulating air if a blower component moves out of place. The devices are rigged to sound an alarm in such an event, but delayed attention could result in serious harm to a patient, according to the FDA.
The watchdog agency gave the ventilator recall Class I status, the most serious category involving "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
Respironics had completed a voluntary recall notification for a limited number of its Trilogy 100 line of ventilators just days prior.
The voluntary recall notification spanned 52 devices, 51 of which have since been removed from use, according to a press release.
The company had received no reports of ventilator malfunctions, injuries or deaths as of the completion of the voluntary recall notification. Other Trilogy models distributed in the U.S., including the 200 and 202 lines, were not affected.
The recall is Respironics’ first Class I since the summer of 2009, when power supply failures led to a recall of several models of the company’s BiPAP noninvasive ventilators.