The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1504-2024·Announced 2024-04-24

Trilogy Evo Ventilator Recall Due to Potential Loss of Ventilation

Philips Respironics is recalling the Trilogy Evo ventilator (76,713 units) because it may suddenly stop ventilating when a false Battery Depleted or Loss of Power alarm triggers despite sufficient power available.

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, which establishes a minimum severity score of 4. The hazard involves potential sudden loss of ventilation on a critical care device serving vulnerable populations dependent on mechanical ventilation. No deaths or serious injuries have been reported, so the score does not rise to Critical.

Plain-English summary

The FDA has classified a recall of the Trilogy Evo ventilator (manufactured by Philips Respironics) as Class I. The recall addresses a potential safety issue where the ventilator may suddenly cease ventilation when it incorrectly triggers a Battery Depleted or Loss of Power alarm, despite having sufficient power available. This malfunction could interrupt critical respiratory support for dependent patients.

The recall affects 76,713 units of the Trilogy Evo. All software versions are affected except version 1.05.06.00. The affected ventilators are distributed nationwide in the United States and internationally to multiple countries.

The recall impacts patients who depend on mechanical ventilation for survival. This includes both pediatric and adult patients using the Trilogy Evo in home care, hospital, and clinical settings.

Patients and healthcare providers should contact Philips Respironics for information about software updates, device replacement, or other mitigation measures. Details about specific affected model numbers and distribution are available through the FDA recall notice.

The recalled product

Product
Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator
Hazard
Affected units
76,713

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. AU2110X15B
  • BL2110X15B
  • BL2200X15B
  • BR2110X18B
  • BR2200X18B
  • CA2110X12B
  • CA2200X12B
  • DE2100X13B
  • DE2110X13B
  • DE2200X13B
  • DS2000X11B
  • DS2100X11B
  • DS2110X11B
  • DS2200X11B
  • EE2100X15B
  • EE2110X15B
  • EE2200X15B
  • ES2100X15B
  • ES2110X15B
  • ES2200X15B

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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