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 pediatric and adult 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 that have a software defect causing power alarms to stop working. This could mean critical safety alerts aren't detected, which is dangerous for patients using the device.
The software defect causes the ventilator to lose all power alarms, meaning critical safety warnings like low oxygen or high carbon dioxide levels won't be detected. This could lead to serious health risks if the patient's condition worsens without timely intervention.
Patients using the Trilogy EVO Ventilator for pediatric or adult care, especially those weighing at least 2.5 kg. Healthcare providers and caregivers are most at risk due to potential undetected safety issues.
Check for the model number IN2100X15B on the ventilator. Affected units have specific serial numbers listed in the recall notice, including H256063834784 and others. The ventilator is intended for pediatric through adult patients weighing at least 2.5 kg.
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 guidance on next steps if you have the affected software versions.
The defect causes the ventilator to lose all power alarms, meaning critical safety warnings like low oxygen or high carbon dioxide levels won't be detected. This could lead to serious health risks if the patient's condition worsens without timely intervention.
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 for the model number IN2100X15B and look for the specific serial numbers listed in the recall notice, such as H256063834784.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-0950-2020 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0950-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
