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 that have a software defect causing power alarms to stop working. This could mean critical safety alerts aren't functioning, which is dangerous for patients using the device.
The software defect causes the ventilator to lose all power alarms, meaning it won't alert users to critical issues like low oxygen or high carbon dioxide levels. This could lead to serious health risks if the patient's condition deteriorates without warning.
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 loss of critical safety alerts.
Check for the model number IN2110X15B on the ventilator. Affected units have specific serial numbers listed in the recall notice, including H23502245F792 and others starting with H25787.
Verify the model number on your ventilator; affected units have the model number IN2110X15B.
Reach out to Philips Respironics directly to confirm if your unit is affected and get instructions for next steps.
The software defect causes power alarms to stop working, which could lead to critical safety issues if the patient's condition worsens without alerts.
Software versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00 are affected.
Check for the model number IN2110X15B and specific serial numbers listed in the recall notice, such as H23502245F792.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-0942-2020 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0942-2020 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.
