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 leading to safety concerns 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 triggered, 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 IT2100X21B are most at risk.
Check for the model number IT2100X21B on the device or its packaging. The ventilator was sold in Italy with serial numbers starting with H24371481043C, H243714900C6D, or H24371504C78D.
Review the software version on the ventilator to see if it matches 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 whether a software update or other remedy is needed.
Check if your ventilator has the model number IT2100X21B and software versions listed in the recall notice. If so, it may be affected.
Contact Philips Respironics directly for instructions on updating the software or other remedies.
Patients using the ventilator for pediatric or adult care weighing at least 2.5 kg are most at risk due to the potential for undetected critical issues.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-0951-2020 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0951-2020 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.
