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FDA Categorizes Philips’ Respiratory Device Recall as Most Critical

The U.S. Food and Drug Administration (FDA) has recently declared the recall of Philips’ respiratory machines, which includes models like Trilogy Evo, Evo O2, and EV300, as the highest level of seriousness. This classification was made due to potential risks of significant injuries or fatalities linked to their use. Philips initiated the recall on March 29, 2023 affecting approximately 73,000 units in the United States. The recall was prompted by the detection of environmental contaminants such as dust and dirt within the air pathways of certain devices, which are vital for assisting individuals with respiratory issues to maintain consistent breathing. To date, the FDA has received 542 reports concerning this problem, including two injuries and one death. The distribution of these devices spanned from March 26, 2019, to March 22, 2023.

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