Philips Respironics recalls Trilogy EVO Ventilators with specific software versions due to power alarm failure, risking undetected equipment malfunction during patient use.
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 of a software defect that causes power alarms to stop working. This could lead to undetected equipment failure while patients are using the device, which is critical for medical safety.
The software defect causes all power alarms to become inoperative, meaning the ventilator cannot alert users to potential equipment failure. This could result in undetected malfunction during critical patient care, especially if the ventilator is not properly monitored.
Patients using the recalled Trilogy EVO Ventilators for pediatric or adult care (weighing at least 2.5 kg) who have the specific software versions listed in the recall. Those with the affected serial numbers are most at risk.
Check if your Trilogy EVO Ventilator has the model number EU2110X15B and the specific serial numbers listed in the recall. The device is intended for patients weighing at least 2.5 kg.
Verify your ventilator's software version 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 for guidance on next steps if your device is affected.
The software defect causes power alarms to become inoperative, which could lead to undetected equipment failure during patient use.
Patients using the Trilogy EVO Ventilator for pediatric or adult care (weighing at least 2.5 kg) with the specific model number EU2110X15B and affected software versions.
Check for the model number EU2110X15B and the specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-0945-2020 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0945-2020 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.
