BEUDAMED
    FDA Enforcement Class II Terminated

    OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic procedures. These tables are suitable to use for diagnostic x-ray imaging and imaging during therapeutic procedures such as spinal injections, vertebroplasty procedures and other pain management procedures. The CFLU Table is designed for Lithotripsy and Urology procedures. It is intended to be operated by a healthcare professional in a medical environment. No special training is required but a review of the Safety Instructions is important for the safety of the operator and patient.

    Recall: Z-1411-2019 · Reported May 29, 2019

    Enforcement

    Recall Number
    Z-1411-2019
    Event ID
    82852
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Oakworks Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2019
    Initiation Date
    May 2, 2019
    Classification Date
    May 23, 2019
    Termination Date
    July 8, 2019
    Address
    923 E Wellspring Rd, N/A, New Freedom, PA, 17349-8408, United States

    Description

    OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic tables intended for use with mobile or compact stationary C-arm Imaging Systems. It is ideally suited for pain management imaging and therapeutic procedures. These tables are suitable to use for diagnostic x-ray imaging and imaging during therapeutic procedures such as spinal injections, vertebroplasty procedures and other pain management procedures. The CFLU Table is designed for Lithotripsy and Urology procedures. It is intended to be operated by a healthcare professional in a medical environment. No special training is required but a review of the Safety Instructions is important for the safety of the operator and patient.

    Reason

    Table assembly error with incorrect actuators for the lateral and longitudinal table movements

    Code Info

    Serial numbers:FLL745088, FLL745089, and FLL745090.

    Distribution

    US Nationwide distribution in the state of SC.

    Quantity

    3 units