Reported Mar 12, 2014 · Terminated

Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the…

Phillips Respironics, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Phillips Respironics, Inc. · 1001 Murry Ridge Ln · Murrysville, PA · 15668-8517

Is this the product you have?

  • 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 UseThe 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 UseThe 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
Lot codes and dates

78 of 78 products

Products covered by this recall
#Product as published
11040000 Trilogy 202 International, Number 1040005 Trilogy200 USA, 1054096 Trilogy 100 International, 1054260 Trilogy 100 USA, 1040004 Trilogy 02, and 1058180 Garbin. Multiple serial numbers also indicated: TV114011447
2TV114011448
3TV114011449 TV11401144A
4TV11401144B
5TV11401144C
6TV11401144D
7TV11401144E
8TV114011450
9TV114011451
10TV11401145B
11TV11401145C
12TV11401145D
13TV11401145F
14TV114011460
15TV114011461
16TV114011462
17TV114011464
18TV114012326
19TV114012364
20TV1140120A9
Amount recalled
572

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 17, 2015 · Data as of Sep 19, 4:52 PM UTC

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