Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ve
FDA device recall Z-2024-2012 · posted 2012-07-23 · Terminated
Recall details
- Recalling firm
- Respironics, Inc.
- Reason for recall
- The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.
- Action taken
- 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..
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 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, J
- Date initiated
- 2012-04-27
- Date posted
- 2012-07-23
- Date terminated
- 2012-11-01
- Location
- Murrysville, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRILOGY 202 VENTILATOR (K093905) | Respironics, Inc. | 2010-05-12 |
| TRILOGY 200 VENTILATOR (K093416) | Respironics, Inc. | 2010-01-29 |
| TRILOGY 100 VENTILATOR (K083526) | Respironics Inc., Sleep & Home Respiratory Group | 2009-03-13 |