Philips Respironics recalls Trilogy Evo ventilators with specific material 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 specific models of Trilogy Evo ventilators that used non-conforming sound abatement foam. This foam may degrade into particles that could be inhaled or ingested by users, especially if unapproved cleaning methods are used or the device is new.
The ventilators used non-conforming polyester-based polyurethane (PE-PUR) sound abatement foam from a supplier. This foam can degrade into particles that may enter the device's air pathway and be inhaled or ingested by users. The risk is higher if unapproved cleaning methods like ozone cleaners are used or during initial device use when the foam off-gases chemicals.
Individuals who own or use Trilogy Evo ventilators with the specified material numbers (DS2110X11B in the USA and KR2110X15B in Korea) are affected. Patients using these ventilators for mechanical ventilation are most at risk.
Check for the material numbers DS2110X11B (USA) or KR2110X15B (Korea) on the ventilator. The product identifiers (serial numbers) listed in the recall include many specific codes starting with H312, H296, H3122, etc.
Look for the product identifier (serial number) on the ventilator to see if it matches the listed codes.
If the device is affected, contact Philips Respironics for instructions on how to return or replace the device.
The affected material numbers are DS2110X11B (USA) and KR2110X15B (Korea).
The non-conforming PE-PUR foam may degrade into particles that enter the air pathway and be inhaled or ingested by users, especially during initial use or with unapproved cleaning methods.
The recall does not specify a return process, but affected users should contact Philips Respironics for instructions.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-0493-2022 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0493-2022 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.
