BEUDAMED
    FDA Recall Terminated

    The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.

    Recall: Z-0371-2017 · Initiated September 27, 2016

    Recall

    Recall Number
    Z-0371-2017
    Event Number
    75288
    Firm
    Schaerer Medical USA Inc
    FEI Number
    1525725
    Product Code
    JEB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 27, 2016
    Terminated
    July 17, 2020
    Address
    675 Wilmer Ave, Cincinnati, OH, 45226-1802

    Description

    The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.

    Reason

    The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak.

    Action

    Schaerer Medical sent a Field action letters dated September 27, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The customer is required to complete and return a response form with the number of affected tables and cylinders. All affected cylinders will be replaced in the field and returned to the manufacturer. For questions Quality Assurance at 513-272 -9116.

    Distribution

    Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA, and VA Replcement cylinders wre distributed

    Quantity

    4 surgical tables with defective floor locking cylinders were distributed. Each table contains 3 cylinders for a total of 12 cylinders.