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Open, Classified

Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use

FDA Recall Z-2106-2023 · Posted 2023-07-07

Recall StatusOpen, Classified
Product CodeCBK
Date Initiated2023-05-25
Product Quantity1,581 units

Reason for Recall

There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".

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 recall notification.

Root Cause

Under Investigation by firm

Distribution Pattern

Foreign Distribution: Korea.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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