Recall Z-1956-2021— Philips Respironics, Inc.

Name: FDA recall Z-1956-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-14

Class I · Ongoing

Class I FDA medical device recall by Philips Respironics, Inc., initiated 2021-06-14. It names 3 FDA 510(k) clearances: K111610, K093416, K083526. Product: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.. Reason: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals..

Recalling firm: Philips Respironics, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2021-06-14
Firm location: Murrysville, PA, United States

510(k) clearances named in this recall

3 on FDA's record

K111610 — TRILOGY SERIES VENTILATOR WITH OXIMETRYRespironics, Inc.·cleared 2011-10-14
K093416 — TRILOGY 200 VENTILATORRespironics, Inc.·cleared 2010-01-29
K083526 — TRILOGY 100 VENTILATORRespironics Inc., Sleep & Home Respiratory Group·cleared 2009-03-13

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.

Reason for recall

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

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