Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
FDA Recall Z-2106-2023 · Posted 2023-07-07
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Recalling FirmPhilips Respironics, Inc.
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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