Philips Respironics recalls LifeVent EVO Ventilators with specific software versions due to power alarm failure risk. Affected units may not alert users to critical issues, potentially causing safety hazards.
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 LifeVent EVO Ventilators with certain software versions because a defect causes power alarms to stop working. This means the device might not warn users of critical issues, which could lead to serious health risks for patients using the ventilator.
The software defect causes the ventilator to lose all power alarms, meaning it won't alert users to critical issues like low oxygen levels or other emergencies. This could lead to undetected problems that might harm patients.
Patients using the LifeVent EVO Ventilator with specific software versions (SP2100X26B model) for pediatric or adult care. Those with the affected serial numbers are most at risk.
Check for the model number SP2100X26B and serial numbers listed in the recall notice. The ventilator is intended for patients weighing at least 2.5 kg.
Verify 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 updating the software or other remedies.
The ventilator may not function safely if the software defect causes power alarms to fail. Affected units should be checked for the specific software versions.
Contact Philips Respironics directly to update the software or get further instructions for safe use.
Check the model number (SP2100X26B) and serial numbers listed in the recall notice. Affected units have specific software versions that cause power alarms to stop working.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-0954-2020 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0954-2020 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.
