Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy E...
FDA Device Recall #Z-0494-2022 — Class I — December 22, 2021
Recall Summary
| Recall Number | Z-0494-2022 |
| Classification | Class I — Serious risk |
| Date Initiated | December 22, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Respironics, Inc. |
| Location | Murrysville, PA |
| Product Type | Devices |
| Quantity | 205 kits |
Product Description
Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.
Reason for Recall
Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.
Distribution Pattern
Worldwide Distribution: Distributed to the following US states: AR, CO, FL, IA, IL, KY, LA, MI, MT, OH, PA, TN, TX, UT, VA, WV, and WY; and Distributed to the following foreign countries: Argentina, Brazil, Romania, and Netherlands.
Lot / Code Information
Lot Numbers 210414 - 210524
Other Recalls from Philips Respironics, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1617-2026 | Class I | Philips Respironics Trilogy Evo Universal, Soft... | Mar 2, 2026 |
| Z-1646-2026 | Class I | Philips Respironics Trilogy Evo, Software Versi... | Mar 2, 2026 |
| Z-1615-2026 | Class I | Philips Respironics Trilogy Evo O2, Software Ve... | Mar 2, 2026 |
| Z-1616-2026 | Class I | Philips Respironics Trilogy EV300, Software Ver... | Mar 2, 2026 |
| Z-1614-2026 | Class I | Philips Respironics Trilogy Evo, Software Versi... | Mar 2, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.