BEUDAMED
    FDA Enforcement Class II Ongoing

    Cascade IOMAX Cortical Module, REF: 190296-200

    Recall: Z-2349-2024 · Reported July 24, 2024

    Enforcement

    Recall Number
    Z-2349-2024
    Event ID
    94764
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cadwell Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2024
    Initiation Date
    May 17, 2024
    Classification Date
    July 12, 2024
    Address
    909 N Kellogg St, Kennewick, WA, 99336-7669, United States

    Description

    Cascade IOMAX Cortical Module, REF: 190296-200

    Reason

    Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.

    Code Info

    UDI: 00840067100653/Serial Numbers:19029603AA0224001, 19029603AA0224002, 19029603AA0224003, 19029603AA0224004,19029603AA0224005, 19029603AA0224006, 19029603AA0224007, 19029603AA0224008, 19029603AA0224010, 19029603AA0224021, 19029603AA0224027, 19029603AA0324006, 19029603AA0324007, 19029603AA0324008, 19029603AA0324009, 19029603AA0324010, 19029603AA0424001, 19029603AA0424002, 19029603AA0424003, 19029603AA0424006, 19029603AA0424007, 19029603AA0424008, 19029603AA0424009, 19029603AA0424010, 19029603AA0524003, 19029603AA0524004

    Distribution

    US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom

    Quantity

    26 units