The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1503-2024·Announced 2024-04-24

Trilogy Evo O2 Ventilator Recalled for Potential Sudden Loss of Ventilation

Philips Respironics is recalling 789 Trilogy Evo O2 ventilators due to a software defect that can trigger a false power alarm despite sufficient power, potentially causing sudden loss of ventilation in pediatric and adult 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 medical device recall for a life-support ventilator. The rubric mandates a minimum Severe rating for Class I recalls. Although no injuries or deaths are reported in the source material, the critical safety risk posed by sudden loss of ventilation in a life-support device justifies the Severe classification.

Plain-English summary

Philips Respironics is recalling the Trilogy Evo O2 ventilator, used by pediatric and adult patients requiring respiratory support. The recall affects 789 units across all software versions except 1.05.06.00, distributed nationwide in the United States and to numerous countries internationally.

A software defect can cause the ventilator to trigger a false Battery Depleted or Loss of Power alarm despite the device having sufficient power. When this false alarm occurs, the ventilator may stop providing ventilation, causing sudden loss of respiratory support to the patient.

Patients and healthcare providers should contact Philips Respironics regarding this recall and for guidance on their devices. Because the Trilogy Evo O2 is essential for patient respiratory function, any concerns should be discussed with the patient's healthcare provider.

The recalled product

Product
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator / Respiratory Equipment
Hazard
Affected units
789

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 No. EE2100X15B
  • FR2100X14B
  • DE2100X13B
  • ES2100X15B
  • IA2100X15B
  • IT2100X21B
  • ND2100X15B
  • UDI-DI: 606959055698
  • 606959055643
  • 606959054103
  • 606959054097
  • 606959055636
  • 606959055438
  • 606959055650
  • Serial No. H800104584B7E
  • H80018230A0E7
  • H8001823283F5
  • H80018233927C
  • H800182382CAF
  • H2623419512AA

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

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 →

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