BEUDAMED
    FDA Recall Terminated

    Ergolift 400 Lbs. Floor Lift, Manufactured by BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada, J1X 5Y5; model/part numbers ERGOLIFT and ERGOLIFT-2 The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.

    Recall: Z-0933-2009 · Initiated December 8, 2008

    Recall

    Recall Number
    Z-0933-2009
    Event Number
    50756
    Firm
    Arjo, Inc.
    FEI Number
    1419652
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 8, 2008
    Posted
    January 30, 2009
    Terminated
    January 21, 2011
    Address
    50 Gary Ave, Roselle, IL, 60172-1605

    Description

    Ergolift 400 Lbs. Floor Lift, Manufactured by BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada, J1X 5Y5; model/part numbers ERGOLIFT and ERGOLIFT-2 The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.

    Reason

    The manufacturer, BHM Medical, has received reports of structural failure of the mast during use.

    Action

    Arjo sent the Urgent Device Recall letter dated 12/22/08 and Field Safety Notice (FSN) dated 12/8/08 to their Ergolift customers on 12/22/08. The accounts were informed of the potential structural failure of the mast on the BHM Medical Ergolift. The letter instructed the accounts to discontinue use of the lifts immediately. Those lifts with serial numbers ERLI-0001 and ERLI-0899 will be taken out of service permanently, and will be replaced with a new device at a significant discount. Those lifts with serial numbers ERLI-0900 and ERLI-1717 will be corrected by a reinforcement kit installed by a qualified technician. The accounts were requested to complete and return to Arjo Inc. within 10 days the enclosed customer response form indicating that they have received the notification, indicating the serial numbers on hand needing correction, and whether they need any replacement lifts. The accounts will be contacted by an Arjo technician within weeks to arrange for the correction of the lifts and/or an Arjo representative for the replacement lifts.

    Distribution

    Nationwide Distribution.

    Quantity

    220 lifts