FDA-Device2023-06-14Class I
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
Philips Respironics, Inc.
Hazard
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.
Sold states
US Nationwide. Global Distribution.
Affected count
18,855 devices
Manufactured in
1001 Murry Ridge Ln, Murrysville, PA, United States
Products
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1651-2023Don't want to check this manually?
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