BEUDAMED
    FDA Recall Terminated

    Foot Controls impacted for the following devices: OAKWORKS Medical CFPM 300 Imaging Table OAKWORKS Medical CFPM 301 Imaging Table OAKWORKS Medical CFPM 400 Imaging Table OAKWORKS Medical CFPM 401 Imaging Table OAKWORKS Medical CFPMB 301 Bariatric Imaging Table OAKWORKS Medical CFUR 301 Urology Table OAKWORKS Medical CFUR 401 Urology Table OAKWORKS Medical CFLU 401 Lithotripsy/Urology Table

    Recall: Z-0703-2018 · Initiated July 31, 2017

    Recall

    Recall Number
    Z-0703-2018
    Event Number
    79107
    Firm
    Oakworks Inc
    FEI Number
    1000121370
    Product Code
    IXR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 31, 2017
    Posted
    February 23, 2018
    Terminated
    March 29, 2019
    Address
    923 E Wellspring Rd, New Freedom, PA, 17349-8408

    Description

    Foot Controls impacted for the following devices: OAKWORKS Medical CFPM 300 Imaging Table OAKWORKS Medical CFPM 301 Imaging Table OAKWORKS Medical CFPM 400 Imaging Table OAKWORKS Medical CFPM 401 Imaging Table OAKWORKS Medical CFPMB 301 Bariatric Imaging Table OAKWORKS Medical CFUR 301 Urology Table OAKWORKS Medical CFUR 401 Urology Table OAKWORKS Medical CFLU 401 Lithotripsy/Urology Table

    Reason

    The foot control used on the OAKWORKS Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR301, CFUR401 and CFLU401 Imaging Tables can become lodged under the base or under the column of the table.

    Action

    OAKWORKS, Inc. issued a MEDICAL DEVICE ADVISORY NOTICE dated 8/18/2017 to customers providing more information in regards to the Medical Device Advisory Notice sent on May 12, 2017. The advisory notice was initiated in response to reported issues with the foot control. OakWorks, Inc. customer service will place the order for the appropriate Foot Control Kit listed below based on what table is impacted and the date of manufacture. PN 2015-204 - Foot Control Kit - Standard Riser 2015-209 - Foot Control Kit - Thinner Riser 2015-210 - Foot Control Kit - Holder Only 2015-211 - Foot Control Kit - Riser Removal Customers with questions may contact 1-800-558-8850 or 1-717-235-6807.

    Distribution

    USA (nationwide) Distribution

    Quantity

    1,104