Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
Reported: June 14, 2023 Initiated: May 1, 2023 #Z-1651-2023
Product Description
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
Reason for Recall
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
Details
- Recalling Firm
- Philips Respironics, Inc.
- Units Affected
- 18,855 devices
- Distribution
- US Nationwide. Global Distribution.
- Location
- Murrysville, PA
Frequently Asked Questions
What product was recalled? ▼
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B. Recalled by Philips Respironics, Inc.. Units affected: 18,855 devices.
Why was this product recalled? ▼
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2023. Severity: Critical. Recall number: Z-1651-2023.
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