FDA recall Z-0785-2022

Philips Respironics, Inc. · Class I · device

Product

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.

Reason for recall

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 This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.

Distribution

Global Distribution. US Nationwide.

Key facts

Status
Ongoing
Initiation date
2018-06-12
Report date
2022-03-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Murrysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0785-2022