Recall Z-2024-2012— Respironics, Inc.

Name: FDA recall Z-2024-2012
Creator: U.S. Food and Drug Administration
Published: 2012-04-27

Class I · Terminated

Class I FDA medical device recall by Respironics, Inc., initiated 2012-04-27, terminated 2012-11-01. It names 3 FDA 510(k) clearances: K093905, K093416, K083526. Product: Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are 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. They are not intended to be used as a transport ventilator.. Reason: The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply..

Recalling firm: Respironics, Inc.
Classification: Class I
Status: Terminated
Initiated: 2012-04-27
Terminated: 2012-11-01
Firm location: Murrysville, 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

Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are 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. They are not intended to be used as a transport ventilator.

Reason for recall

The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.

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