Philips Respironics recalls Trilogy EVO Ventilators with specific software versions due to power alarm failure risk. Affected units may not alert to critical issues, potentially causing safety hazards for patients.
Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.
Philips Respironics is recalling certain Trilogy EVO Ventilators because a software defect causes power alarms to stop working. This means the device might not warn users of critical problems, which could be dangerous for patients using the ventilator.
The software defect causes the ventilator to lose all power alarms, meaning it won't alert users to critical issues like low oxygen or other emergencies. This could lead to undetected problems that might harm patients if the ventilator fails to provide necessary support.
Patients using the Trilogy EVO Ventilator for pediatric or adult care (weighing at least 2.5 kg) with specific model numbers and serial numbers listed in the recall. Those with the affected software versions are most at risk.
Check for the model number EU2100X15B and serial numbers listed in the recall (e.g., H23987675BB18, H243715497B08). The ventilator is intended for patients weighing at least 2.5 kg and is sold in the EU region.
Review the software version on your ventilator to see if it matches the affected versions: SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, or SW 1.01.11.00.
Reach out to Philips Respironics directly for assistance with the recall or to get the necessary software update.
The affected software versions are SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00.
Check the model number (EU2100X15B) and serial numbers listed in the recall, such as H23987675BB18 or H243715497B08.
No, but you should check the software version and contact Philips Respironics for guidance on the 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-0953-2020 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0953-2020 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.
