Philips Respironics recalls Trilogy EV300 Portable Electric Ventilators with specific model numbers due to potential oxygen delivery inaccuracies below required tolerance, which could 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 specific models of their Trilogy EV300 portable ventilators because they may deliver less oxygen than set, risking under-delivery during high concentration therapy. This could cause unsafe oxygen levels for patients using the device.
The ventilator's oxygen delivery may deviate below the required 5% tolerance from 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.
Patients using the recalled Trilogy EV300 ventilators for medical oxygen therapy are most at risk. The specific model numbers and serial numbers are listed in the recall notice.
Check if your Trilogy EV300 ventilator has model numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, or other listed model numbers. The device also has specific serial numbers listed in the recall notice.
Look for model numbers on your device: DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, or other listed models.
Reach out to Philips Respironics for assistance with the recall process and to confirm if your device is affected.
The affected model numbers are DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, and other specific model numbers listed in the recall notice.
The recall is happening because the oxygen delivery may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy, potentially causing under-delivery of oxygen.
No, the recall does not require immediate discontinuation of use. However, you should check if your device is affected and contact Philips Respironics for guidance.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-1288-2023 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-1288-2023 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.
