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 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 in Great Britain because of a software defect that can cause all power alarms to stop working. This means the device might not alert users to critical problems, which could be dangerous for patients using the ventilator.
The software defect causes the ventilator to lose all power alarms, meaning critical safety alerts like low oxygen or high carbon dioxide levels may not sound. This could lead to undetected issues that might harm the patient if the ventilator fails to function properly.
Patients using the Trilogy EVO Ventilator for pediatric or adult care in Great Britain are affected. Those with the specific model number GB2110X15B and listed serial numbers are most at risk.
Check for the model number GB2110X15B on the ventilator. Affected units have specific serial numbers listed in the recall notice, including H24736983B2CC and others.
Review 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 next steps, as the recall does not specify a fix or replacement.
No, only specific models with the model number GB2110X15B and listed serial numbers in Great Britain.
The recall does not specify a fix or replacement, so contact Philips Respironics directly for guidance.
The recall states the defect causes loss of all power alarms, which could lead to undetected issues, but it does not explicitly state a risk of serious injury.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-0947-2020 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0947-2020 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.
