FDA-Device2022-03-30Class I
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
Philips Respironics, Inc.
Hazard
In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.
Sold states
Global Distribution. US Nationwide.
Affected count
229,353 devices
Manufactured in
1001 Murry Ridge Ln, N/A, Murrysville, PA, United States
Products
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0785-2022Don't want to check this manually?
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