Recall Z-1652-2023 ยท CBK Ventilator, Continuous, Facility Use
Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, Model Number DS2000X11B
| Date | Jun 2, 2023 (initiated May 1, 2023) |
| Status | Open, Classified |
| Reason | The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventila |
| Root cause | Under Investigation by firm |
| Action | An URGENT Medical Device Correction notification letter was sent to customers on 5/1/23. Please take the actions below in order to prevent risk for your patients. Actions that must be taken by the user in order to prevent risks for patients. To help prevent accumulation of debris on the machine flow sensor: Use the Philips approved particulate filter which prevents a significant majority of airborne aerosols and particulate from entering the device. This filter must be replaced between patients and monthly as indicated in the Instructions for Use. Using this filter was previously optional. Th |
| Quantity | 22,237 devices |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181170 | Trilogy Evo Universal Respironics, Inc., Jul 18, 2019 |