Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
FDA device recall Z-2106-2023 · posted 2023-07-07 · Open, Classified
Recall details
- Recalling firm
- Philips Respironics, Inc.
- Reason for recall
- There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
- Action taken
- 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 recall notification.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- CBK
- Quantity affected
- 1,581 units
- Distribution
- Foreign Distribution: Korea.
- Date initiated
- 2023-05-25
- Date posted
- 2023-07-07
- Location
- Murrysville, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Trilogy Evo (K181166) | Respironics, Inc. | 2019-07-18 |