Philips Respironics recalls Trilogy EVO Ventilators with specific software versions due to power alarm failure risk. Affected models include ND2110X15B with serial numbers listed. This defect may cause loss of critical safety alerts.
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 Trilogy EVO Ventilators with certain software versions because a defect causes power alarms to stop working. This could lead to missing critical safety alerts during use, especially for patients needing ventilator support.
The software defect causes the ventilator to lose all power alarms, meaning critical safety alerts that monitor patient conditions may not function properly. This could result in undetected issues with the patient's breathing or other vital functions if the ventilator fails to alert the user.
Patients using the Trilogy EVO Ventilator for pediatric or adult care (weighing at least 2.5 kg) with the specific model and software versions listed are affected. Those with the recalled software versions are most at risk.
Check for the model number ND2110X15B on the ventilator. The specific software versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00 are affected. Serial numbers listed in the recall include H251017836F15 and others.
Review the software version on your ventilator to see if it matches the affected versions listed in the recall.
Reach out to Philips Respironics for guidance on next steps if your ventilator is affected.
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 ND2110X15B and the specific software versions listed in the recall. Serial numbers like H251017836F15 are also affected.
Contact Philips Respironics for guidance on next steps, as the recall does not specify a fix or replacement.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-0948-2020 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0948-2020 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.
