Recall Z-0882-2023 ยท CBK Ventilator, Continuous, Facility Use
Philips Respironics, Inc.
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096, KR1054096, R1054655TP, R1054655B, 1054655, 1054655TPV, 1054655TP, 1054655B
| Date | Jan 6, 2023 (initiated Dec 7, 2022) |
| Status | Open, Classified |
| Reason | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm. |
| Root cause | Process design |
| Action | Telephone calls and URGENT Medical Device Recall notification letters were distributed beginning 12/6/22. Actions you must take as a device owner or healthcare provider to prevent risks for patients. Device is on patients: For affected Trilogy 100 and Trilogy 200 devices that are on patients, ensure that your clinical assessment of the patients is up to date, reflecting the true acuity of the patients and their respiratory therapy requirements. Your patient may experience serious harm if their device malfunctions and immediate intervention is not available. Until Philips Respironics is able |
| Quantity | 20,807 |
| Distribution | US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083526 | TRILOGY 100 VENTILATOR Respironics Inc., Sleep & Home Respiratory Group, Mar 13, 2009 |