BEUDAMED
    FDA Recall Terminated

    Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.

    Recall: Z-2023-2014 · Initiated June 25, 2014

    Recall

    Recall Number
    Z-2023-2014
    Event Number
    68399
    Firm
    Invacare Corporation
    FEI Number
    1525712
    Product Code
    INN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 25, 2014
    Posted
    July 9, 2014
    Terminated
    April 15, 2015
    Address
    1200 Taylor St, Elyria, OH, 44035-6248

    Description

    Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.

    Reason

    The Aquatec Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame.

    Action

    The recall notification will be sent to the two consignees informing them of the recall and to notify their customers. The letter will include a provider letter, customer letter, provider response card and impacted units listing.

    Distribution

    Distributed in PA and Canada.

    Quantity

    465 units