Philips Respironics recalls Trilogy Evo ventilators with specific lot numbers due to non-conforming sound abatement foam that may degrade into particles and be inhaled by users.
Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.
Philips Respironics is recalling Trilogy Evo ventilators with specific lot numbers because they contain non-conforming sound abatement foam that may degrade into particles and be inhaled by users. This poses a risk of respiratory issues if the foam degrades during use or cleaning.
The ventilator contains non-conforming sound abatement foam that may degrade into particles during use. These particles could be inhaled by users, potentially causing respiratory issues. Unapproved cleaning methods like ozone cleaners may worsen the degradation.
Patients using Trilogy Evo ventilators with lot numbers 210414 to 210524 are affected. Those with respiratory conditions or using unapproved cleaning methods are at higher risk.
Check the lot number on the device or repair kit, which ranges from 210414 to 210524. The Trilogy Evo ventilator is designed for pediatric through adult patients weighing at least 2.5 kg.
Identify the lot number on the device or repair kit to confirm if it falls within 210414 to 210524.
The non-conforming foam may degrade into particles that can be inhaled by users, potentially causing respiratory issues.
Unapproved cleaning methods like ozone cleaners may worsen the foam degradation, increasing the risk of particle release.
The recall record does not specify a remedy.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-0494-2022 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0494-2022 from Philips Respironics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
