BEUDAMED
    FDA Recall Terminated

    BHM Medical Scales, 1000 lb. scales weight limit; Part Number 700.00525; Manufactured by BHM Medical Inc., Magog, QC, Canada; These scales were sold for installation on the Model V10 and Model Maxisky fixed ceiling lifts manufactured by BHM Medical.

    Recall: Z-1136-2008 · Initiated December 19, 2007

    Recall

    Recall Number
    Z-1136-2008
    Event Number
    46210
    Firm
    Arjo, Inc.
    FEI Number
    1419652
    Product Code
    FRW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 19, 2007
    Posted
    February 26, 2008
    Terminated
    November 18, 2009
    Address
    50 Gary Ave, Ste A, Roselle, IL, 60172-1684

    Description

    BHM Medical Scales, 1000 lb. scales weight limit; Part Number 700.00525; Manufactured by BHM Medical Inc., Magog, QC, Canada; These scales were sold for installation on the Model V10 and Model Maxisky fixed ceiling lifts manufactured by BHM Medical.

    Reason

    Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall.

    Action

    Arjo sent Urgent Device Field Correction Notification letters dated 12/19/07 to the end user accounts who received the affected scales, advising them of the potential for the hanger bar assembly to detach. The accounts were given the option immediately stopping use of the lifts with the affected scales or removing the scales from the lift so the lift can continue to be used. Instructions for removal of the scales were provided with the letter. The accounts were requested to complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter, and indicating whether they will complete the correction upon receipt of the correction parts or if they require the assistance of an Arjo Service Technician.

    Distribution

    Nationwide including the states of Alabama, Arizona, California, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Washington and Wisconsin.

    Quantity

    26 scales