Philips Trilogy Evo Portable Ventilators Recalled for Inaccurate Oxygen Delivery
Philips Respironics is recalling the Trilogy Evo Universal Portable Electric Ventilator (Model DS2000X11B) because it may deliver oxygen below the prescribed level during high-concentration oxygen therapy, potentially depriving patients of adequate oxygen.
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 medical device recall designation. Although no deaths or reported illnesses are mentioned in the source, the potential for oxygen delivery failure in ventilator-dependent patients creates serious risk of respiratory complications.
Plain-English summary
Philips Respironics is recalling the Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B. Approximately 62,826 devices are affected, distributed worldwide including throughout the United States and Puerto Rico.
The device may deliver oxygen below the required tolerance level of 5% from the set amount during high-concentration oxygen therapy. Additionally, if equipped with an internal FiO2 sensor, the sensor may display a value higher than what the device is actually delivering, resulting in patients receiving less oxygen than prescribed.
Patients dependent on this ventilator for high-concentration oxygen therapy may experience inadequate oxygen delivery, which could lead to serious respiratory complications.
Affected users should contact their healthcare provider or Philips Respironics immediately for guidance. Do not discontinue device use without consulting your healthcare provider about alternatives.
The recalled product
- Product
- Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
- Manufacturer
- Philips Respironics, Inc.
- Affected units
- 62,826
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 (20)
- Model number: DS2000X11B
- UDI-DI: 606959052000. Serial Numbers: H27736231F4BE
- H277362379188
- H27736246CD09
- H277372867812
- H27737288916C
- H2773729661CA
- H27737302AA2A
- H27737306EC0E
- H2773730914F9
- H27737331B2D9
- H27737344A87C
- H277373468B6E
- H277373596A41
- H277373815671
- H2773738401DC
- H2773740998FC
- H277374132E7E
- H277374212704
- H277374525897
Distribution
Part of a larger recall action
This product is one of 3 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 3 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
- SevereTrilogy Evo O2 obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- SevereTrilogy Evo obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
- 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
Similar recalls
- SevereTrilogy Evo Universal Ventilator Recalled Due to Sensor Malfunction Risk
FDA (Devices) · 2024-11-20
- SevereTrilogy Evo Universal Ventilator Class I Recall—22,237 Units Affected
FDA (Devices) · 2023-06-14
- SeverePhilips Trilogy Evo ventilators recall: flow sensor fouling risk
FDA (Devices) · 2024-11-20
- SeverePhilips Trilogy Evo Ventilator Recall: Potential Loss of Ventilation Due to False Alarm
FDA (Devices) · 2024-04-24
- SevereTrilogy Evo Ventilator Recall Due to Potential Loss of Ventilation
FDA (Devices) · 2024-04-24
- HighTrilogy Evo Respiratory Device Recalled for Software Pressure Issues
FDA (Devices) · 2021-08-25