The Recall Desk
SevereFDA (Devices)·Z-1651-2023·Announced 2023-06-14

Trilogy Evo O2 EV300 respiratory devices recalled for debris accumulation

Philips Respironics recalled 18,855 Trilogy Evo O2 EV300 devices because environmental debris may accumulate on the flow sensor, potentially causing inaccurate delivery of pressure or flow. This could result in patient hypoxemia if not promptly addressed.

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: This is an FDA Class I recall for a medical device with serious potential for patient harm through hypoxemia. No adverse events have been reported yet, but the FDA Class I designation and the mechanism of potential failure indicate substantial risk that would result in serious injury if the device malfunctions during clinical use.

Plain-English summary

Philips Respironics, Inc. is recalling 18,855 Trilogy Evo O2 EV300 respiratory devices. Affected model numbers are DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B. These devices are distributed nationwide in the United States and globally.

Environmental debris may accumulate on the internal machine flow sensor, causing partial occlusion that may impact accurate delivery of pressure, volume, or flow to patients. A malfunction from this issue can result in patient harm up to hypoxemia if not addressed by the care provider.

Patients using Trilogy Evo O2 EV300 devices for respiratory support may be affected. Care providers should be aware of this potential hazard and monitor devices for any signs of malfunction.

The recalled product

Product
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Respiratory / Ventilator
Hazard
Affected units
18,855

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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