The Recall Desk
SevereFDA (Devices)·Z-1505-2024·Announced 2024-04-24

Philips Trilogy Evo Ventilator Recall: Potential Loss of Ventilation Due to False Alarm

Philips is recalling the Trilogy Evo Universal Ventilator for a software defect that triggers false low-battery or power-loss alarms despite sufficient power, risking sudden ventilation loss.

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 classification applies to this recall. The rule requires never going below severity 4 for Class I medical device recalls. Although no illnesses or deaths are reported, the potential for sudden loss of ventilation in a critical life-support device justifies the Severe score.

Plain-English summary

Philips Respironics, Inc. is recalling the Trilogy Evo Universal Ventilator (all software versions except 1.05.06.00), a device used for pediatric and adult patients. Approximately 9,999 units have been distributed nationwide and internationally. The affected model is DS2000X11B with UDI-DI 606959052000.

A software defect may cause the ventilator to display a 'Battery Depleted' or 'Loss of Power' alarm even when the unit has sufficient power. This false alarm condition could result in sudden loss of ventilation, creating a risk to patients who depend on the device for breathing support.

Patients and healthcare providers should verify they are running software version 1.05.06.00, which is not affected by this issue. Devices with other software versions should be updated to version 1.05.06.00 or discontinued from use. Contact Philips Respironics for technical support or software updates.

The recalled product

Product
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Respiratory / Ventilator
Hazard
  • loss-of-ventilation
  • false-alarm

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 (3)

  • Model No. DS2000X11B
  • UDI-DI: 606959052000
  • All units except those with software version 1.05.06.00.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category