Trilogy EV300 ventilator: potential flow sensor malfunction from aerosol accumulation
Philips Respironics is recalling 34,146 Trilogy EV300 ventilators due to potential aerosol accumulation on the internal flow sensor, which could cause inaccurate ventilation measurements.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity of 4 per the rubric. Inaccurate flow measurements in a ventilator used for pediatric through adult patients could result in serious adverse health consequences.
Plain-English summary
Philips Respironics is recalling 34,146 units of the Trilogy EV300 ventilator worldwide. The device is a portable ventilator intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg, used in hospitals, homes, and non-emergency transport settings.
In certain locations, an in-line nebulizer configuration can allow aerosol deposits to accumulate on the device's internal flow sensor. This accumulation can lead to inaccurate flow measurements, potentially resulting in improper ventilation settings or patient care.
This is an FDA Class I recall affecting devices distributed worldwide. Patients and healthcare providers with affected Trilogy EV300 ventilators should contact Philips Respironics immediately for guidance on corrective measures or device replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Respiratory
- Affected units
- 34,146
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 (17)
- 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.
Distribution
Part of a larger recall action
This product is one of 7 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Philips Respironics, Inc.
See all →- SevereTrilogy EV300 obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
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- SevereTrilogy Evo obstruction alarm may take up to four breaths
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- SevereTrilogy Evo Universal obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy EV300 ventilator recalled as Class I over tidal volume
FDA (Devices) · 2026-04-01
Same hazard · aerosol accumulation
See all →- SevereTrilogy Evo Universal Ventilator Recalled Due to Sensor Malfunction Risk
FDA (Devices) · 2024-11-20
- SeverePhilips LifeVent EVO2 ventilators recalled for potential sensor accuracy failure
FDA (Devices) · 2024-11-20
- SevereVentilator Model LD2110X23B Recalled for Potential Sensor Measurement Failure
FDA (Devices) · 2024-11-20
- SeverePhilips Trilogy Evo ventilators recall: flow sensor fouling risk
FDA (Devices) · 2024-11-20
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