Z-2024-2012Class I

Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or...

Name: Z-2024-2012 Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or...
Creator: Respironics, Inc.
Published: 2012-04-27
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2012-04-27 / Terminated / root cause: design

FDA source

Respironics, Inc. began a recall of Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of... on 2012-04-27. FDA classified it as Class I and gives the reason as "The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2024-2012
Classification: Class I
Status: Terminated
Initiated: 2012-04-27
Posted: 2012-07-23
Terminated: 2012-11-01
Recalling firm: Respironics, Inc.
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.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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..
Quantity in commerce: 173
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 codes and lots: Model/Catalog Numbers: 1032800, 1040004, 1040007, 1054096, 1054260, CA1032800, R1040004, R1054655, and 1045151.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2024-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2024-2012	Class I	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-23

Product code CBK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)