Recall Z-2106-2023 ยท CBK Ventilator, Continuous, Facility Use
Philips Respironics, Inc.
Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
| Date | Jul 7, 2023 (initiated May 25, 2023) |
| Status | Open, Classified |
| Reason | There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive". |
| Root cause | Under Investigation by firm |
| Action | Customers were mailed a recall notification dated 05/23/2023 identifying the reason for recall as a mistranslation from "invasive" to "non-invasive" in the Korean IFUs. Customers are to refer to the correct instructions as listed in the recall notification when referring to the updated IFU pages, keep a copy of the recall notification with the IFU, communicate the recall notification to all who need to be aware in their organization, and complete and return the provided Field Safety Notice Response Form. The response form can be returned to the Philips representative indicated in your specific |
| Quantity | 1,581 units |
| Distribution | Foreign Distribution: Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181166 | Trilogy Evo Respironics, Inc., Jul 18, 2019 |