CLASS I ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report
Trilogy EV300 recalled by Philips Respironics
Philips Respironics is recalling Trilogy EV300, distributed nationwide in the US. The recall was initiated on 7 Oct 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0293-2025
- FDA event ID
- 95486
- Recalling firm
- Philips Respironics, Murrysville, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 7 Oct 2024
- FDA classified
- 13 Nov 2024
- Reported
- 20 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 7 Oct 2024 | Recall initiated by company | |
| 13 Nov 2024 | Classified by FDA | +37 days |
| 20 Nov 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Product as listed by the FDA
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, LY, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, TZ, UA, UY, VN, YT, ZA, ZW.
Nationwide ArkansasCaliforniaColoradoDelawareIdahoIllinoisIndianaMassachusettsMaineMontanaPennsylvaniaTennessee
Questions about this recall
Why was it recalled?
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Which lots are affected?
Model Number (UDI-DI Number): DS2200X11B (606959052017); IN2200X15B (606959056497); BL2200X15B (606959058668); BR2200X18B (606959058583); CA2200X12B (606959052321); DE2200X13B (606959058651); GB2200X15B (606959058675); ND2200X15B (606959058620); ES2200X15B (606959058644); FR2200X14B (606959058613); FX2200X15B (606959061033); EU2200X15B (606959058682); IA2200X15B (606959058606); IT2200X21B (606959058637); KR2200X15B (606959058590); TR2200X15B (606959058798); EE2200X15B (606959058705). All Serial Numbers.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, LY, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, TZ, UA, UY, VN, YT, ZA, ZW.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 95486This product is part of a recall event; the main page for the event is Trilogy Evo Universal Ventilator recalled by Philips Respironics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Trilogy Evo Universal Ventilator recalled by Philips Respironics | Philips Respironics | Labeling Errors | Nationwide | |
| CLASS I | Aeris EVO recalled by Philips Respironics | Philips Respironics | Labeling Errors | Nationwide | |
| CLASS I | Garbin Evo recalled by Philips Respironics | Philips Respironics | Labeling Errors | Nationwide | |
| CLASS I | LifeVent EVO2 recalled by Philips Respironics | Philips Respironics | Labeling Errors | Nationwide | |
| CLASS I | Trilogy Evo O2 recalled by Philips Respironics | Philips Respironics | Labeling Errors | Nationwide | |
| CLASS I | Trilogy Evo recalled by Philips Respironics | Philips Respironics | Labeling Errors | Nationwide |
More recalls from Philips Respironics
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Trilogy Evo recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
| Device | CLASS I | Trilogy EV300 recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
| Device | CLASS I | Trilogy Evo Universal recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
| Device | CLASS I | Trilogy Evo O2 recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
| Device | CLASS I | Trilogy Evo recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide |
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