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Philips Respironics, Inc. recalls Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800,
Recalled January 18, 2023 · FDA recall Z-0883-2023 · Philips Respironics
Hazard
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm. · FDA Class I
Units
537 devices
Sold at
US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.
Description
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
Product
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
Manufacturer(s)
Philips Respironics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →