BEUDAMED
    FDA Recall Open, Classified

    Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

    Recall: Z-1663-2025 · Initiated March 27, 2025

    Recall

    Recall Number
    Z-1663-2025
    Event Number
    96581
    Firm
    IHB OPERATIONS B.V. Floresstraat 52 Zwolle Netherlands
    FEI Number
    3006800085
    Product Code
    FQO
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    March 27, 2025
    Posted
    April 23, 2025

    Description

    Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

    Reason

    The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware and subsequent separation of the frame from the mounting column.

    Action

    Skytron issued a Field Correction notice to its service personnel on 03/27/2025 via email. The notice explained the issue, risk to health, and requested the following: Customer Acknowledgement 1. Contact customers to ensure they have received the customer letter. 2. Provide a copy of the customer letter if needed. 3. Document who you spoke with and the date of contact on the Customer Acknowledgement Spreadsheet. Customer Acknowledgement Spreadsheet will be provided by Quality. 4. Return the completed Customer Acknowledgement Spreadsheet to [email protected]. The devices will be corrected on site. Skytron notified the medical facilities (users of the device) by issuing an URGENT: MEDICAL DEVICE RECALL notice on 03/28/2025 via US Mail. This letter explained the issue, risk to health and requested the following: Actions to be taken by Customer/User: Prior to the field correction, you should take the following precautionary measures to mitigate any potential risks: Inspect your 4FXS-60 frames to ensure that all 4 mounting screws are secure. If any loose connections are identified, immediately remove the 4FXS-60 from use and notify your local authorized representative. For questions or concerns, please contact your local authorized representative or Skytron at 1-800-759-8766.

    Distribution

    US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, ID, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NM, NY, PA, TN, TX, UT, VA, WI, WV.

    Quantity

    112 units