BEUDAMED
    FDA Recall Terminated

    Foot switch, Part Number 1009.81. Maquet GmbH & Co. KG, 76437 Rastatt, Germany. The foot switches in the 1009.8 1 series are accessory components which can be connected to certain MAQUET operating tables. Several of the table top adjustment motions (depending on the table and foot switch versions in use) can then be executed by the foot. The foot switch is equipped with rocker switches. The switching elements are used to initiate the table top functions.

    Recall: Z-0620-2009 · Initiated December 8, 2008

    Recall

    Recall Number
    Z-0620-2009
    Event Number
    50472
    Firm
    MAQUET Inc.
    FEI Number
    3008355164
    Product Code
    FWZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 8, 2008
    Posted
    January 15, 2009
    Terminated
    June 18, 2012
    Address
    1140 US Highway 22, Bridgewater, NJ, 08807-2958

    Description

    Foot switch, Part Number 1009.81. Maquet GmbH & Co. KG, 76437 Rastatt, Germany. The foot switches in the 1009.8 1 series are accessory components which can be connected to certain MAQUET operating tables. Several of the table top adjustment motions (depending on the table and foot switch versions in use) can then be executed by the foot. The foot switch is equipped with rocker switches. The switching elements are used to initiate the table top functions.

    Reason

    A bearing point of the pedal of the foot switch may come loose. With continued use of the foot switch, one or both springs beneath the pedal can fall out of their mounting, and it is possible the pedal comes to rest on the switch causing an unintended motion of the operating table during patient use.

    Action

    An Urgent Device Correction letter (with an enclosed Customer Response form) was sent via Federal Express on Monday, December 8, 2008 to all customers who had received tables. Customers were notified in the letter of the problem and actions to be taken including not to use any affected foot pedal for safety reasons. In addition, customers were instructed to complete and return the Customer Response Form via fax (732-667-1903) to Maquet Inc. Please call USA Maquet, Inc. at toll free number 1-888-627-8383 #1 (then select the option for Surgical Workplace products) for questions.

    Distribution

    Worldwide Distribution.

    Quantity

    587 units total (54 units in US)