Philips Respironics recalls Trilogy EVO Ventilators with specific software versions due to power alarm failure. This defect may lead to incorrect readings and safety risks for patients using medical ventilators.
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 lead to incorrect readings and safety risks for patients using medical ventilators.
The software defect causes the ventilator to lose all power alarms, which are critical for detecting issues like low oxygen or high carbon dioxide levels. Without functioning alarms, healthcare providers may not detect problems in time, potentially leading to serious health risks for patients.
Patients using the Trilogy EVO Ventilator for medical purposes, particularly those requiring respiratory support. Healthcare providers and caregivers are most at risk due to potential safety issues.
Check for the model number ES2100X15B and serial numbers starting with H24371562F66B on the ventilator. The product was sold in the Iberia region with specific software versions SW 1.00.05 through SW 1.01.11.00.
Identify the software version on your ventilator to see if it matches the affected versions SW 1.00.05 through SW 1.01.11.00.
Reach out to Philips Respironics for guidance on next steps if your ventilator is affected by the software defect.
No, only specific models with the model number ES2100X15B and software versions SW 1.00.05 through SW 1.01.11.00 are affected.
Contact Philips Respironics directly for guidance on next steps, as the recall does not include a specific remedy like a repair or replacement.
Yes, the power alarms failing could lead to incorrect readings and potential safety risks for patients using the ventilator.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-0952-2020 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0952-2020 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.
