BEUDAMED
    FDA Enforcement Class II Terminated

    Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homecare setting, at nursing homes and other assisted living centers. Please note that the DPS can be utilized only if affixed to ceiling lift or passive floor lift.

    Recall: Z-1100-2021 · Reported February 17, 2021

    Enforcement

    Recall Number
    Z-1100-2021
    Event ID
    86578
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arjohuntleigh Magog, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2021
    Initiation Date
    October 6, 2020
    Classification Date
    February 9, 2021
    Termination Date
    July 23, 2025
    Address
    2001 Tanguay St, N/A, Magog, N/A, N/A, Canada

    Description

    Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homecare setting, at nursing homes and other assisted living centers. Please note that the DPS can be utilized only if affixed to ceiling lift or passive floor lift.

    Reason

    Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS)

    Code Info

    LBA1030-xx, LCA80563-xx, LCA81695-xx, KTX01440.xx, LBX05420-xx, LBX1033-xx, KTS0010

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, GA, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NH, NY, OH, OK, SC, SD, TN, TX, UT, VA, WI and the countries of Australia, Belgium, Canada, Czech Republic, France, Italy and Poland.

    Quantity

    3390 units