Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen
The Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen during high-concentration therapy due to accuracy deviations. The device's internal oxygen sensor may also display incorrect readings, creating a risk of oxygen under-delivery to patients.
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: FDA Class I recall of a critical respiratory device with oxygen under-delivery hazard. Although no reported injuries, the defect poses significant risk to ventilator-dependent patients requiring reliable oxygen therapy.
Plain-English summary
The Trilogy EV300 Portable Electric Ventilator (manufactured by Philips Respironics, Inc.) is being recalled due to a defect affecting oxygen delivery accuracy.
The device may deliver oxygen below the required tolerance of 5% from the programmed setpoint during high-concentration oxygen therapy. Additionally, the internal FiO2 sensor may indicate a value higher than the device is actually delivering, which could mask the under-delivery of oxygen to clinicians monitoring the patient.
This recall affects approximately 62,826 Trilogy EV300 devices distributed worldwide, including throughout the US and Puerto Rico and in many other countries.
Patients and healthcare providers using the Trilogy EV300 should contact Philips Respironics, Inc. for further instructions. Patients should not discontinue use without consulting their healthcare provider, as respiratory support is critical. Healthcare providers should verify oxygen delivery is adequate when using this device.
The recalled product
- Product
- Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B, TR2200X
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- oxygen-under-delivery
- sensor-malfunction
- oxygen-accuracy-error
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)
- UDI-DI: 606959052017
- 606959056497
- 606959061033
- 606959052321
- 606959058613
- 606959058620
- 606959058644
- 606959058668
- 606959058675
- 606959058682
- 606959058705
- 606959058798
- 606959052000. UDI-DI
- Model number: Serial numbers 606959052017
- DS2200X11B: H27990931E388
- H27990933C09A
- H27990934B425
- H279909369737
- H28068115E37D
- H28068117C06F
Distribution
Distributed nationwide across the United States.
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