The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1652-2023·Announced 2023-06-14

Trilogy Evo Universal Ventilator Class I Recall—22,237 Units Affected

The FDA has issued a Class I recall for the Trilogy Evo Universal Ventilator Model DS2000X11B, affecting 22,237 units distributed nationwide and globally. The device is manufactured by Philips Respironics, Inc.

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 of a medical device. According to the severity rubric, FDA Class I recalls cannot score below 4 (Severe). Class I designations indicate a reasonable probability that use of the defective product will cause serious adverse health consequences or death.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for the Trilogy Evo Universal Ventilator, Model Number DS2000X11B, manufactured by Philips Respironics, Inc. A total of 22,237 units have been recalled. The affected devices have been distributed nationwide in the United States and globally.

The Trilogy Evo Universal Ventilator is a respiratory support device intended for pediatric through adult patients weighing at least 2.5 kg who require mechanical ventilation. It provides continuous or intermittent positive pressure ventilation and, when integrated with appropriate accessories, can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data. The ventilator is designed for use in institutional and hospital settings as well as non-emergency transport settings such as wheelchair environments, and supports both invasive and non-invasive ventilation modes.

The Class I recall classification reflects an FDA determination that there is a reasonable probability that use or exposure to the defective product will cause serious adverse health consequences or death.

The recalled product

Product
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator
Affected units
22,237

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 (1)

  • UDI-DI: 606959052000

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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