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 problems if the patient's condition worsens without warning.
Patients using the Trilogy EVO Ventilator for pediatric or adult care, especially those weighing at least 2.5 kg. Those with the specific model number FR2110X14B are most at risk.
Check for the model number FR2110X14B on the ventilator. The serial numbers listed (H248213027F13, H249718745CF4, etc.) are also affected. These units were sold in France.
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 for guidance on next steps if your ventilator is affected.
The software defect causes power alarms to stop working, which could lead to critical safety issues if the patient's condition worsens without warning.
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 FR2110X14B and the listed serial numbers (H248213027F13, H249718745CF4, etc.) on your device.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-0949-2020 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0949-2020 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.
