BEUDAMED
    FDA Enforcement Class II Terminated

    The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nursing homes, hospitals and home care. The Concerto Basic Shower Trolley is intended for indoor use.

    Recall: Z-1388-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1388-2016
    Event ID
    73054
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arjo, Inc. dba ArjoHuntleigh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2016
    Initiation Date
    December 21, 2015
    Classification Date
    April 13, 2016
    Termination Date
    June 25, 2018
    Address
    2349 W Lake St, N/A, Addison, IL, 60101-6183, United States

    Description

    The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nursing homes, hospitals and home care. The Concerto Basic Shower Trolley is intended for indoor use.

    Reason

    Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.

    Code Info

    All Concerto & Basic Shower Trolleys manufactured by ArjoHuntleigh Polska Sp. z o.o, March 7, 2014 through April 20, 2015 with serial numbers from P0227559 - P0322393

    Distribution

    US Consignees; 222 units distributed in the following states: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV. ***Foreign Consignees; 1374 units distributed in the following countries: Australia, Austria, Belgium, Bosnia & Hercegovina, Brazil, CANADA, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Iceland, Ireland, Italy, Japan, Lithuania, Luxemburg, Netherlands, New Zealand, Nigeria, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan and UK.

    Quantity

    1,596 units