Recall Z-0785-2022— Philips Respironics, Inc.

Name: FDA recall Z-0785-2022
Creator: U.S. Food and Drug Administration
Published: 2018-06-12

Class I · Ongoing

Class I FDA medical device recall by Philips Respironics, Inc., initiated 2018-06-12. It names one FDA 510(k) clearance: K111610. 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: 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 This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices..

Recalling firm: Philips Respironics, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2018-06-12
Firm location: Murrysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K111610 — TRILOGY SERIES VENTILATOR WITH OXIMETRYRespironics, Inc.·cleared 2011-10-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.

Data sourced from openFDA. This site is unofficial and independent of the FDA.