BEUDAMED
    FDA Recall Terminated

    Minstrel Patient Lift with SR weighing scale; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model number HMB002-US

    Recall: Z-0478-2007 · Initiated August 31, 2006

    Recall

    Recall Number
    Z-0478-2007
    Event Number
    36187
    Firm
    Arjo, Inc.
    FEI Number
    1419652
    Product Code
    FNG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 31, 2006
    Posted
    January 11, 2007
    Terminated
    October 16, 2008
    Address
    50 Gary Ave, Roselle, IL, 60172-1605

    Description

    Minstrel Patient Lift with SR weighing scale; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model number HMB002-US

    Reason

    The hanger bar assembly may detach from the lift during use due to fatigue failure of the bolt.

    Action

    Arjo sent an Urgent Device Field Correction Recall letter dated 8/31/06 to all affected end users to the attention of the Administrator/Risk Manager via FedEx on the same date. The letters informed the accounts of the potential for the hanger bar to detach from the scale due to fatigue failure of the pivot bolt. The accounts were advised that an Arjo Field Service Technician would contact them within five business days to schedule a visit to the account to perform an upgrade of their Minstrel lifts. Any questions were directed to Arjo Quality Department at 800-323-1245, ext. 6140.

    Distribution

    Nationwide

    Quantity

    76 lifts