Portable Electric Ventilators May Deliver Insufficient Oxygen During High-Concentration Therapy
Philips Respironics ventilators may deliver oxygen below required tolerance during high-concentration therapy. The FiO2 sensor may display higher readings than actual delivery, risking insufficient oxygen 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: This is an FDA Class I recall for a critical life-support device. The severity rubric requires a minimum score of 4 for Class I recalls. While no deaths or hospitalizations are explicitly reported, oxygen under-delivery in a portable ventilator poses serious risk of harm to dependent patients.
Plain-English summary
Philips Respironics is recalling the Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilators. These devices have been identified as having a potential accuracy issue with oxygen delivery.
The delivered oxygen may deviate below the required tolerance of 5% from the setpoint when providing high-concentration oxygen therapy. Additionally, the internal FiO2 sensor may indicate a higher value than the device is actually delivering. This may result in under-delivery of oxygen to patients.
The recall affects 62,826 total devices distributed worldwide, including throughout the United States and Puerto Rico, as well as 55 other countries. The devices are identified by multiple model numbers listed in the FDA notification.
The recalled product
- Product
- Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- oxygen-under-delivery
- sensor-accuracy-failure
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: 606959051997
- 606959054059
- 606959055575
- 606959061019
- 606959055599
- 606959055636
- 606959062085
- 606959055643
- 606959055650
- 606959055438
- 606959054097
- 606959054103
- 606959055674
- 606959055681
- 606959055698. UDI-DI
- Model Number: Serial numbers. 606959054103
- DE2100X13B: H236054270DD5
- H23630215A1ED
- H23630353F967
- H23708996882F
Distribution
Distributed nationwide across the United States.
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