BEUDAMED
    FDA Recall Terminated

    Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed

    Recall: Z-2411-2011 · Initiated May 2, 2011

    Recall

    Recall Number
    Z-2411-2011
    Event Number
    58785
    Firm
    Linet Americas Inc
    FEI Number
    3008007426
    Product Code
    FNK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 2, 2011
    Posted
    June 3, 2011
    Terminated
    July 19, 2012
    Address
    10430 Harris Oak Blvd, Ste A, Charlotte, NC, 28269-7511

    Description

    Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed

    Reason

    Linet has been made aware that there has been breakage of the Mobi-lift handle on a few beds which may cause failure during patient assist use.

    Action

    The firm, Linet America, notified US customers only via phone on May 5, 2011. A follow up "service advisory information" letter dated May 11, 2011 was sent to all customers. The letter described the product, problem and action to be taken. The customers were instructed to remind/retrain staff to ensure that the Mobi-lift handles are always in the stowed position during patient transport and after use, and complete and return the attached Inspection procedure for each affected Eleganza 3 bed via mail to: Linet Americas, 10420-R Harris Oaks Blvd., Charlotte, NC 28269 or fax to: 704-248-5655. Linet Americas will be receiving a supply of new Mobi-lift design and will begin the process of executing service calls to replace the Morbi-lift handles with the new design. If you have any questions, contact the Director of Quality and Service Operations at 704-248-5650 or 980-406-6446.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: KY, MA, NC, and NY; and country of: Canada.

    Quantity

    1601 units