Trilogy Evo O2 Ventilators Recalled for Potential Flow Sensor Malfunction
Philips Respironics recalled 24,249 Trilogy Evo O2 ventilators because in-line nebulizer configurations may allow aerosol deposits to accumulate on the device's flow sensor, potentially causing inaccurate flow measurements.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls must never score below 4. No reported illnesses or deaths are mentioned in the source, which precludes a Critical (5) rating, but the classification and the potential for measurement errors in a critical respiratory device justify the Severe classification.
Plain-English summary
Philips Respironics is recalling 24,249 units of the Trilogy Evo O2 ventilator. This device is intended for invasive and non-invasive ventilation of pediatric and adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings. The recalled units have been distributed worldwide, including the United States.
The recall addresses a potential hazard in which an in-line nebulizer configuration in certain locations may result in aerosol deposit accumulation on the device's internal flow sensor. This accumulation could lead to inaccurate flow measurements.
Affected patients and healthcare providers should contact Philips Respironics for information about this recall.
The recalled product
- Product
- Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pedi
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- sensor-fouling
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Model Number (UDI-DI Number): DE2100X13B (606959054103)
- DS2100X11B (606959051997)
- EE2100X15B (606959055698)
- ES2100X15B (606959054097)
- EU2100X15B (606959055674)
- EU2100X19 (606959055681)
- FP2100X10 (606959062085)
- FR2100X14B (606959055643)
- FX2100X15B (606959061019)
- IA2100X15B (606959055636)
- IN2100X15B (606959054059)
- IN2100X19 (606959055575)
- IT2100X21B (606959055438)
- JP2100X16B (606959055582)
- LA2100X15B (606959055599)
- ND2100X15B (606959055650). All Serial Numbers.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03