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.
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 because of a software defect that causes power alarms to stop working. This could mean critical safety alerts aren't detected, which is dangerous for patients using the device.
The software defect causes the ventilator to lose all power alarms, meaning critical safety alerts like low oxygen or high carbon dioxide levels won't sound. 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. Healthcare providers and caregivers are most at risk due to potential undetected safety issues.
Check for model number ES2110X15B and serial numbers starting with H25123324AA45, H2512383941DE, H251239768495, H25124050192C, H251250171648, H25125051141E, or H2512510467D7. The ventilator is intended for patients weighing at least 2.5 kg.
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 the next steps, as they may provide a software update or other remedy.
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 model number ES2110X15B and serial numbers starting with H25123324AA45, H2512383941DE, H251239768495, H25124050192C, H251250171648, H25125051141E, or H2512510467D7.
The recall record does not specify a remedy, so contact Philips Respironics for updates.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-0943-2020 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0943-2020 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.
