Recall Z-2024-2012 ยท CBK Ventilator, Continuous, Facility Use
Respironics, Inc.
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 w
| Date | Jul 23, 2012 (initiated Apr 27, 2012) |
| Status | Terminated |
| Reason | The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply. |
| 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 | 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. |
| FDA record | Open on fda.gov |