BEUDAMED
    FDA Recall Terminated

    Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); Mast scale is Intended to be used for weighing patients while in the lifter. Manufactured by Medi-Man Rehabilitation Products Inc., 6200A Tomken Road, Mississauga, Ontario, Canada L5T 1X7, now owned by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5

    Recall: Z-1557-2008 · Initiated April 10, 2008

    Recall

    Recall Number
    Z-1557-2008
    Event Number
    47456
    Firm
    Arjo, Inc.
    FEI Number
    1419652
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 10, 2008
    Posted
    July 30, 2008
    Terminated
    November 18, 2009
    Address
    50 Gary Ave, Ste A, Roselle, IL, 60172-1684

    Description

    Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); Mast scale is Intended to be used for weighing patients while in the lifter. Manufactured by Medi-Man Rehabilitation Products Inc., 6200A Tomken Road, Mississauga, Ontario, Canada L5T 1X7, now owned by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5

    Reason

    Scale could break and fall potentially causing injuries to someone who is on it. There is a potential for the mast scale load cell ssembly to fracture and allow the mast/boom to fall. Should a patient be in the lift at the time, the patient could fall and sustain injuries.

    Action

    Arjo sent Urgent Device Recall Customer Notification letters dated 4/1/08 on the BHM Medical letterhead to the end user accounts who received the affected patient lifts with mast scales, advising them of the potential of fracture at the load cell assembly which might cause the scale to fall. Should a patient be in the lift at the time, the patient could fall, potentially sustaining injuries. The accounts were instructed to immediately stop using the patient lifts. A BHM representative will contact the accounts within 5 days to arrange for the correction of the lifts. The accounts will be given the option of returning the lifts for repair (with shipping costs covered by BHM), or purchasing a replacement lift at a significantly reduced price. Any questions or concerns were directed to the BHM Service Department at 1-819-868-0441 or [email protected].

    Distribution

    Nationwide Distribution --- including states of California, Florida, Illinois, Michigan, Minnesota, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Washington, and Wyoming.

    Quantity

    37 lifts