Recall Z-1651-2023 ยท CBK Ventilator, Continuous, Facility Use
Philips Respironics, Inc.
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
| Date | Jun 2, 2023 (initiated May 1, 2023) |
| Status | Open, Classified |
| Reason | Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider. |
| 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 | 18,855 devices |
| Distribution | US Nationwide. Global Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181166 | Trilogy Evo Respironics, Inc., Jul 18, 2019 |