BEUDAMED
    FDA Enforcement Class II 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 · Reported November 16, 2016

    Enforcement

    Recall Number
    Z-0371-2017
    Event ID
    75288
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Schaerer Medical USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 16, 2016
    Initiation Date
    September 27, 2016
    Classification Date
    November 8, 2016
    Termination Date
    July 17, 2020
    Address
    675 Wilmer Ave, Cincinnati, OH, 45226-1802, United States

    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.

    Code Info

    Lot Codes for the four (4) model 7300 Surgical Tables TFX-1653, TFX1654, TFX1655, TFX1656

    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.