CLASS I ONGOING Device recall · Reported 24 Apr 2024 · FDA Enforcement Report
Trilogy EV300, all recalled by Philips Respironics
Philips Respironics is recalling Trilogy EV300, all, distributed nationwide in the US. The recall was initiated on 19 Mar 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-1502-2024
- FDA event ID
- 94263
- Recalling firm
- Philips Respironics, Murrysville, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 19 Mar 2024
- FDA classified
- 17 Apr 2024
- Reported
- 24 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 19 Mar 2024 | Recall initiated by company | |
| 17 Apr 2024 | Classified by FDA | +29 days |
| 24 Apr 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 sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Where it was distributed
Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, 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, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, 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, US, UY, VN, YT, ZA, ZW.
Nationwide ArkansasCaliforniaColoradoDelawareIdahoIllinoisIndianaMassachusettsMaineMontanaPennsylvaniaPuerto RicoTennessee
Questions about this recall
Why was it recalled?
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Which lots are affected?
Model No. BL2200X15B, BR2200X18B, CA2200X12B, EE2200X15B, EU2100X15B, EU2100X19, EU2200X15B, FR2200X14B, DE2200X13B, GB2200X15B, FX2100X15B, FX2200X15B, IN2100X15B, IN2100X19, IN2200X15B, IT2200X21B, JP2100X16B, KR2200X15B, LA2100X15B, ND2200X15B, ES2200X15B, TR2200X15B, DS2100X11B, DS2200X11B, UDI-DI: 606959058668, 606959058583, 606959052321, 606959058705, 606959055674, 606959055681, 606959058682, 606959058613, 606959058651, 606959058675, 606959061019, 606959061033, 606959054059, 606959055575, 606959056497, 606959058637, 606959055582, 606959058590, 606959055599, 606959058620, 606959058644, 606959058798, 606959051997, 606959052017; All units except those with software version 1.05.06.00.
Where was it sold?
Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, 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, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, 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, US, 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 94263This product is part of a recall event; the main page for the event is Trilogy Evo Universal Ventilator, all recalled by Philips Respironics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Trilogy Evo Universal Ventilator, all recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide | |
| CLASS I | LifeVentEVO2, all recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide | |
| CLASS I | Aeris EVO, all recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide | |
| CLASS I | Trilogy Evo O2, all recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide | |
| CLASS I | Garbin EVO, all recalled by Philips Respironics | Philips Respironics | Device Malfunction | Nationwide | |
| CLASS I | Trilogy Evo, all recalled by Philips Respironics | Philips Respironics | Device Malfunction | 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 |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |