Philips Respironics recalls Trilogy Evo O2 and LifeVentEVO2 portable ventilators with model numbers DS2100X11B, IN2100X15B, IN2100X19, etc. for inaccurate oxygen delivery that may lead to under-delivery of oxygen during high concentration therapy.
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
Philips Respironics is recalling certain Trilogy Evo O2 and LifeVentEVO2 portable ventilators because they may deliver less oxygen than set, risking under-delivery of oxygen during high concentration therapy. This could be dangerous for people relying on these devices for breathing support.
The ventilators may deliver less oxygen than the set target (by up to 5% tolerance) when providing high concentration oxygen therapy. This can cause under-delivery of oxygen, which is dangerous for patients needing consistent oxygen levels.
People using these portable ventilators for medical breathing support, especially those with respiratory conditions requiring oxygen therapy. The risk is low for most users but could be serious for those dependent on precise oxygen levels.
Check if your device has model numbers DS2100X11B, IN2100X15B, IN2100X19, or other listed models. The device may also have a UDI-DI code starting with 60695905 or a serial number listed in the detailed serial numbers provided.
Look for model numbers on your device label: DS2100X11B, IN2100X15B, IN2100X19, or other listed models.
Reach out to Philips Respironics for assistance with the recall and to get replacement or repair options.
The ventilators may deliver less oxygen than set, which could lead to under-delivery of oxygen during high concentration therapy. This is a risk for patients relying on precise oxygen levels.
Check if your device has model numbers DS2100X11B, IN2100X15B, IN2100X19, or other listed models. The device may also have a UDI-DI code starting with 60695905 or a serial number listed in the detailed serial numbers provided.
No, but you should check if your device is affected and contact Philips Respironics for guidance on next steps.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-1287-2023 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-1287-2023 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.
