BEUDAMED
    FDA Recall Open, Classified

    Cascade IOMAX Cortical Module, REF: 190296-200

    Recall: Z-1882-2024 · Initiated April 23, 2024

    Recall

    Recall Number
    Z-1882-2024
    Event Number
    94504
    Firm
    Cadwell Industries Inc
    FEI Number
    3020018
    Product Code
    GWF
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    April 23, 2024
    Posted
    May 22, 2024
    Address
    909 N Kellogg St, Kennewick, WA, 99336-7669

    Description

    Cascade IOMAX Cortical Module, REF: 190296-200

    Reason

    There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.

    Action

    On 4/22/24, Cadwell Industries, Inc. issued a "Urgent: Medical Device Recall" notification to affected consignees via Email: 1. Cease use of the device immediately and return all identified devices to Cadwell Industries, Inc. 2. Please complete the attached response form and return via email to [email protected]. 3. Please circulate this notice to all those who require awareness within your organization or to any organization whom you may have transferred the IOMAX Cortical Module to. 4. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    Distribution

    Worldwide - US Nationwide distribution in the state of MD and the countries of Mexico, Canada, Malaysia, India, Taiwan, Saudi Arabia, European Union, Switzerland, South Africa, Iraq, United Kingdom.

    Quantity

    54 units