BEUDAMED
    FDA Recall Terminated

    Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4OLU2FUS

    Recall: Z-0798-2007 · Initiated January 5, 2007

    Recall

    Recall Number
    Z-0798-2007
    Event Number
    37064
    Firm
    Arjo, Inc.
    FEI Number
    1419652
    Product Code
    FSG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 5, 2007
    Posted
    May 11, 2007
    Terminated
    September 2, 2008
    Address
    50 Gary Ave, Ste A, Roselle, IL, 60172-1684

    Description

    Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4OLU2FUS

    Reason

    The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting on the two bolts holding the scale in place.

    Action

    Arjo sent Urgent Device Field Correction Recall Notice letters dated 1/5/07 to the end user accounts who received the affected lifts, advising them of the potential for the hanger bar assembly to detach. They were informed that an Arjo Field Service Technician would call them within five business days to schedule the time for him to visit and perform the inspection and correction to the lifts involved. If they did not hear from the technician within that time, they were instructed to contact the Arjo Quality Department at 800-323-1245, ext. 6140. The accounts were also requested to complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter.

    Distribution

    Nationwide

    Quantity

    146 lifts