Recall Z-1143-2014 ยท CBK Ventilator, Continuous, Facility Use
Phillips Respironics, Inc.
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
| Date | Mar 6, 2014 (initiated Feb 11, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | Philips sent an Urgent - Medical Device Recall letter on February 11, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the Notice with all members of their staff who need to be aware of the contents of the communication. For further information or support concerning the issue, customers were instructed to contact Philips Respironics at 877-387-3311. For questions regarding this recall call 724-733-0200. |
| Quantity | 572 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of France, Great Britian, China, India, Italy, Korea, Kuwait, Nehterlands, and Singapore. |
| FDA record | Open on fda.gov |