Philips Respironics recalls Garbin 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 using 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 Garbin EVO Ventilators with certain software versions because they may stop working and lose all power alarms. This could mean critical safety alerts aren't functioning, which is dangerous for patients using ventilators.
The software defect causes the ventilator to lose all power alarms, meaning it won't alert users to critical issues like low battery or system failures. This could lead to undetected problems that might harm patients if the ventilator stops working unexpectedly.
Patients using the Garbin EVO Ventilator for pediatric or adult care, especially those weighing at least 2.5 kg. Those with medical conditions requiring ventilator support are most at risk.
Check for the model number LD2110X23B and serial numbers listed in the recall notice. The ventilator is intended for patients weighing at least 2.5 kg and is used for medical breathing support.
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 has the affected software versions.
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 the model number LD2110X23B and the serial numbers listed in the recall notice. The ventilator is intended for patients weighing at least 2.5 kg.
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-0946-2020 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-0946-2020 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.