Philips’ (NYSE:PHG) Respironics issued a recall for its Esprit V1000 and V200 ventilators over concerns that machines may fail to operate on AC power.
The FDA classified the action as a Class I recall, meaning that use of the device could result in serious injury or even death. The respirators are used to provide breathing assistance to adults and children, including newborns.
The recall covers Esprit V1000 and Esprit V200 ventilators installed with 3rd generation power supplies and 3rd generation power supply repair kits. The devices were manufactured and distributed between Dec. 21, 2012, and July 9, 2014, according to the FDA.
The FDA said that a component of the 3rd generation power supply may prevent the machine from using AC power or switch back to AC power after battery use.
No deaths or serious injuries were reported in connection with the Sept. 17.
recall. Philips plans to contact customers to about replacing the recalled power supply components with upgraded versions, according to the watchdog agency.