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Philips Respironics, Inc. recalls Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B,
Recalled June 14, 2023 · FDA recall Z-1651-2023 · Philips Respironics
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. · FDA Class I
Units
18,855 devices
Sold at
US Nationwide. Global Distribution.
Description
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.
Product
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
Manufacturer(s)
Philips Respironics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →