Recall Z-1065-2016— Philips Respironics

Name: FDA recall Z-1065-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-18

Class II · Terminated

Class II FDA medical device recall by Philips Respironics, initiated 2016-01-18, terminated 2017-05-26. It names 3 FDA 510(k) clearances: K093905, K093416, K083526. Product: Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.. Reason: Software Issue.

Recalling firm: Philips Respironics
Classification: Class II
Status: Terminated
Initiated: 2016-01-18
Terminated: 2017-05-26
Firm location: Monroeville, PA, United States

510(k) clearances named in this recall

3 on FDA's record

K093905 — TRILOGY 202 VENTILATORRespironics, Inc.·cleared 2010-05-12
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, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

Reason for recall

Software Issue

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