Philips Respironics recalls Trilogy EV300 ventilators with software version 1.05.15.00 due to potential tidal volume discrepancies when using non-pneumatic nebulizers. Affected users should contact Philips for guidance.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Philips Respironics is recalling its Trilogy EV300 continuous home-use ventilators with software version 1.05.15.00. Using non-pneumatic nebulizers with these devices may cause a mismatch between the set and actual tidal volume delivered to patients, which could affect breathing treatment effectiveness.
The software version 1.05.15.00 may not accurately measure the tidal volume when non-pneumatic nebulizers are used. This discrepancy could lead to incorrect breathing support levels, potentially affecting treatment effectiveness but not causing immediate harm.
Patients using the Trilogy EV300 ventilator with software version 1.05.15.00 are affected. Those who use non-pneumatic nebulizers with this device are at higher risk of tidal volume discrepancies.
Check if your ventilator has the model name 'Trilogy EV300' and software version 1.05.15.00. All units with this software version are affected regardless of serial number or UDI.
Verify your ventilator's software version by checking the device settings or manual.
Reach out to Philips Respironics directly for specific instructions on addressing the discrepancy.
Yes, all Trilogy EV300 ventilators with software version 1.05.15.00 are affected.
No, the recall does not require immediate discontinuation of use. Contact Philips for guidance.
The recall specifically mentions that using non-pneumatic nebulizers may cause tidal volume discrepancies. Contact Philips for advice on safe usage.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-1616-2026 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-1616-2026 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.
