The Food and Drug Administration (FDA), on August 14, identified the recall by Philips Respironics of its Trilogy Evo, Evo 02, EV300, and Evo Universal Ventilators as Class I, the most serious.
The recall was initiated after detecting dust and dirt from the environment in the air path of some devices. Extended exposure to such environmental contaminants can lead to buildup that may block air vents and cause the ventilator to stop delivering the correct amount of air pressure or air volume/flow.
The company has received 542 reports about this issue, including two injuries and one death.
Distribution dates were March 26, 2019, to March 22, 2023.
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