BEUDAMED
    FDA Recall Terminated

    Access Hi-Low Exam Tables, Model 6501-XX

    Recall: Z-2531-2018 · Initiated March 29, 2018

    Recall

    Recall Number
    Z-2531-2018
    Event Number
    80164
    Firm
    Brewer Company, LLC N88
    FEI Number
    2182536
    Product Code
    LGX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 29, 2018
    Terminated
    August 29, 2019
    Address
    W13901 Main St, Menomonee Falls, WI, 53051-2330

    Description

    Access Hi-Low Exam Tables, Model 6501-XX

    Reason

    One lot, the wire harness was over-crimped on some of the connectors that go to the two vertical side switches on the exam table.

    Action

    The Brewer Company notified customers, via "MEDICAL DEVICE CORRECTION" letter, on about 03/21/2018. Instructions included to cease distribution of the product, coordinate with Brewer to schedule rework of the cable in affected tables as quickly as possible, and to notify Brewer of customers if the product was further distributed to coordinate rework of those tables. Additionally secondary controls were provided that the operator must press and continually hold the foot control pedal to operate the table, the foot control includes a stop button, depressing any pedal on the foot control will stop the table's automatic movement, and the manual instructs the operator to remove any obstructions from under the exam table prior to movement. Questions can be directed to (888) 273-9371.

    Distribution

    Devices distributed in WI, TX, MN and IL.

    Quantity

    7 devices