Recall Z-0945-2020 ยท CBK Ventilator, Continuous, Facility Use
Philips Respironics, Inc.
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo 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.
| Date | Feb 15, 2020 (initiated Nov 19, 2019) |
| Status | Terminated |
| Reason | Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439. |
| Root cause | Software design |
| Action | On November 19, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: URGENT - Field Safety Notice Trilogy Evo, Garbin Evo, LifeVent Evo 2 Released Software Versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00 Dear Customer, During engineering testing, Philips became aware of two (2) unlikely scenarios that result in the Trilogy Evo failing to alarm immediately and persistently after a loss of therapy event. The failure to alarm as designed is the result of the software on impacted Trilogy Evo devices not reacting properly to these event |
| Quantity | 48 |
| Distribution | US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181166 | Trilogy Evo Respironics, Inc., Jul 18, 2019 |