Phillips Respironics, Inc. recalls Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the c

Recalled March 12, 2014 · FDA recall Z-1143-2014 · Phillips Respironics

Hazard

Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients. · FDA Class I

Units

572

Sold at

Worldwide Distribution - USA (nationwide) and the countries of France, Great Britian, China, India, Italy, Korea, Kuwait, Nehterlands, and Singapore.

Description

Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients.

Product

Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator 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 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. Trilogy 200 Intended Use: The Respironics Trilogy 200 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). 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. Trilogy 202 Intended Use: The Respironics Trilogy 202 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy 202 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in hospitals and institutions, and for portable applications such as wheelchairs and gurneys only when in an institutional setting. It may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

Manufacturer(s)

Phillips Respironics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →