BEUDAMED
    FDA Recall Open, Classified

    GS70 Salus Surgical Table, Product Code 18-070-70

    Recall: Z-2469-2023 · Initiated August 1, 2023

    Recall

    Recall Number
    Z-2469-2023
    Event Number
    92290
    Firm
    Skytron, LLC
    FEI Number
    1825014
    Product Code
    GDC
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 1, 2023
    Posted
    August 28, 2023
    Address
    5085 Corporate Exchange Blvd SE, Grand Rapids, MI, 49512-5515

    Description

    GS70 Salus Surgical Table, Product Code 18-070-70

    Reason

    When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failure could be replicated even in wired mode if communication between the pendant and table were somehow interrupted. The root cause appears to be: if communication between the controller and table is interrupted while a button is pressed, the table does not know if/when a button is released. This occurs in wireless or wired mode.

    Action

    An URGENT: Medical Device Correction dated 7/25/23 was sent to customers. Actions to be taken by the user: 1. Please promptly forward this notification if the device has been transferred to any other entity. 2. Please review appendices of affected serial and UDI numbers and identify devices within your facility. 3. Please do not use the table control in Bluetooth mode until the correction has been installed. 4. Please contact quality at [email protected] with any questions. Skytron authorized service technicians will contact affected facilities to schedule this service. A location with a medical outlet and a power cord for the operating table available will be required to complete the corrective action. Skytron estimates that this correction activity will be completed by December 31, 2023. Please do not use the table control in Bluetooth mode until the correction has been installed.

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, AR, CA, CT, FL, GA, IA, IL, IN, MA, MI, MO, PA, TN, TX, UT, WA, WI and the countries of Australia, New Zealand.

    Quantity

    110 units