Philips Respironics recalls Trilogy Evo Universal Portable Electric Ventilators (Model DS2000X11B) due to potential oxygen delivery inaccuracies below required tolerance, which 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 its Trilogy Evo Universal Portable Electric Ventilators (Model DS2000X11B) because they may deliver less oxygen than set, risking under-delivery during high concentration therapy. This could lead to inadequate oxygen levels for patients needing respiratory support.
The ventilator's oxygen delivery may deviate below the required 5% tolerance from the setpoint when providing high concentration oxygen therapy. Additionally, if equipped with an internal FiO2 sensor, it may indicate a higher oxygen level than what the device is actually delivering, potentially causing under-delivery of oxygen to patients.
Patients using the Trilogy Evo ventilator for respiratory support, particularly those requiring high concentration oxygen therapy, are at risk of receiving less oxygen than prescribed. The device is designed for medical use and not for home use without a doctor's supervision.
Check for the model number DS2000X11B on the device or its packaging. The serial numbers listed in the recall include a range of numbers starting with H27736231F4BE through H29350024E9FC.
Look for the model number DS2000X11B on the device or its packaging.
Reach out to Philips Respironics customer service to confirm if your device is affected and receive instructions.
This recall specifically affects Trilogy Evo Universal Portable Electric Ventilators with model number DS2000X11B. If your device has this model number, it is affected.
Check the model number on your device or its packaging. The recall includes devices with model number DS2000X11B and serial numbers listed in the provided range.
No, but you should contact Philips Respironics to confirm if your device is affected and follow their instructions. The recall does not require immediate discontinuation of use but requires verification.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-1289-2023 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-1289-2023 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.
