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Respironics Trilogy 100, 200, and 202 Ventilators recallZ-2024-2012 · Respironics, Inc. · initiated Apr 27, 2012

Class I Terminated All recalls posted in July 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Respironics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Component design/selection

What the company is doing

Respironics, Inc. began contacting its affected US customers by phone beginning on Friday, April 27, 2012, and requested that they quarantine any affected devices within their possession and that they retrieve any devices with patients and quarantine those as well. Replacement devices were to be provided to all affected customers. For questions customers should call 724-387-7651. For questions regarding this recall call 877-387-3311..

Recall details

Recall number
Z-2024-2012
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Apr 27, 2012
Posted by the FDA
Jul 23, 2012
Recalling firm
Respironics, Inc.
Quantity
173
Product code
CBK
FDA submissions
K083526, K093416, K093905
Distribution
Worldwide Distribution - USA including AZ, CA, IL, IN, LA, MI, MN, MO, NJ, NY, NC, PA, SC, TN, TX, and WI and the countries of Canada, Denmark, Estonia, Finland, France, Great Britian, India, Italy, Japan, Korea, Saudi Arabia, and Spain.

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.

Code information (models, lots, serial numbers)

Model/Catalog Numbers: 1032800, 1040004, 1040007, 1054096, 1054260, CA1032800, R1040004, R1054655, and 1045151.

Other devices under the same FDA submission

44 devices cleared under K083526, K093416, K093905 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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