Philips Respironics is recalling 100,126 Trilogy Evo and Trilogy Evo O2 ventilators because the safety labeling failed to include critical instructions regarding patient weight and use. Specifically, the AVAPS-AE therapy mode must not be used on patients weighing less than 22 pounds (10 kg) or for invasive treatments, and the standard AVAPS feature is also unsafe for patients under 22 pounds. Approximately 54,691 of these affected units were distributed across the United States and Puerto Rico.
If these ventilators are used on patients weighing less than 10 kg, it can cause severe lung injury from excessive pressure, insufficient breathing (hypoventilation), or the dangerous buildup and rebreathing of carbon dioxide.
Label correction for safety contraindications.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES ยท Raw API Response
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