Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B ...
FDA Device Recall #Z-0638-2024 — Class II — November 27, 2023
Recall Summary
| Recall Number | Z-0638-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 27, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Respironics, Inc. |
| Location | Murrysville, PA |
| Product Type | Devices |
| Quantity | 100,126 (54,691 US; 45,435 OUS) in total |
Product Description
Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B EE2110X15B ES2100X15B ES2110X15B EU2100X15B EU2100X19 EU2110X15B FR2100X14B FR2110X14B FX2100X15B GB2110X15B IA2100X15B IA2110X15B IN2100X15B IN2100X19 IN2110X15B IT2100X21B IT2110X21B JP2100X16B JP2110X16B KR2110X15B LA2100X15B LA2110X15B ND2110X15B RDE2100X13B RDE2110X13B RDS2110X11B RIN2100X15B RIN2110X15B RJP2100X16B RJP2110X16B UDS2110X11B
Reason for Recall
The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.
Distribution Pattern
Worldwide distribution: US (nationwide)-AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Including PR; and OUS (International) including countries of: AE, AR,AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, ;EC EE, EG, ES, FI, FR, GB, GE, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JO, JP, KE, KR, KW, LB, LT, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, OM, PA, PE, PF, PH, PK, PL, PR, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, YT, ZA and ZW.
Lot / Code Information
Material UDI-DI/GTIN BL2110X15B 606959055520 BR2110X18B 606959055476 CA2110X12B 606959052307 DE2100X13B 606959054103 DE2110X13B 606959054110 DS2100X11B 606959051997 DS2110X11B 606959051942 EE2100X15B 606959055698 EE2110X15B 606959055544 ES2100X15B 606959054097 ES2110X15B 606959054080 EU2100X15B 606959055674 EU2100X19 606959055681 EU2110X15B 606959054981 FR2100X14B 606959055643 FR2110X14B 606959055506 FX2100X15B 606959061019 GB2110X15B 606959054127 IA2100X15B 606959055636 IA2110X15B 606959055490 IN2100X15B 606959054059 IN2100X19 606959055575 IN2110X15B 606959051959 IT2100X21B 606959055438 IT2110X21B 606959055421 JP2100X16B 606959055582 JP2110X16B 606959051973 KR2110X15B 606959055483 LA2100X15B 606959055599 LA2110X15B 606959055452 ND2110X15B 606959055513 RDE2100X13B RDE2110X13B RDS2110X11B 606959060517 RIN2100X15B RIN2110X15B RJP2100X16B RJP2110X16B UDS2110X11B 606959060500 All units of listed models are affected by this correction.
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-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 |
| Z-0481-2026 | Class II | SimplyGo Mini, Standard Battery Kit; Product c... | Oct 7, 2025 |
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.