The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1287-2023·Announced 2023-04-12

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.

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: 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…
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Portable Ventilator
Hazard
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)

  • 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.

The notice also names 8 states specifically:

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 →

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