BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150

    Recall: Z-1493-2026 · Reported March 11, 2026

    Enforcement

    Recall Number
    Z-1493-2026
    Event ID
    98161
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Advanced Bionics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2026
    Initiation Date
    November 27, 2025
    Classification Date
    March 5, 2026
    Address
    28515 Westinghouse Pl, N/A, Valencia, CA, 91355-1398, United States

    Description

    Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150

    Reason

    Behind-the-ear sound processer packaging label is different then included product.

    Code Info

    Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603

    Distribution

    Unknown

    Quantity

    2 units