BEUDAMED
    FDA Enforcement Class II Terminated

    Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.

    Recall: Z-2113-2012 · Reported August 8, 2012

    Enforcement

    Recall Number
    Z-2113-2012
    Event ID
    62493
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunrise Medical (US) LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 8, 2012
    Initiation Date
    June 26, 2012
    Classification Date
    July 31, 2012
    Termination Date
    November 1, 2012
    Address
    2842 N Business Park Ave, N/A, Fresno, CA, 93727-1328, United States

    Description

    Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.

    Reason

    Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm.

    Code Info

    Receiver Product number 109207.

    Distribution

    Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.

    Quantity

    14, 035