Recall Z-2943-2024 ยท CBK Ventilator, Continuous, Facility Use
Philips Respironics, Inc.
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
| Date | Sep 5, 2024 (initiated Jul 16, 2024) |
| Status | Open, Classified |
| Reason | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls. |
| Root cause | Device Design |
| Action | On July 16, 2024, the firm began notifying customers through letters titled "URGENT Medical Device Correction" - UPDATE. Customers were informed of the release of mandatory software update version 1.05.10.00 and a User Manual addendum for the Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators. This letter outlines the safety issues addressed by this update, previously tracked through recalls RES 91832, 92048, 92515, 93609, and 94263. Issues include "Accuracy of Oxygen Delivery", "Environmental Contamination of Device Sensor", "Battery Depleted or Loss of Power A |
| Quantity | 90,910 US; 56,273 ROW |
| Distribution | Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU, BD, BE, BG, BO, BR, BS, CH, CL, NL, CN, CO, CZ, DE, DK, FR, SE, GB, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JP, KE, KW, LB, LT, MA, ME, MA, MT, MQ, MX, NO, NP, OM, PA, PE, PF, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SI, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181170 | Trilogy Evo Universal Respironics, Inc., Jul 18, 2019 |