BEUDAMED
    FDA Recall Terminated

    Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift; ArjoHuntleigh, Addison, IL 60101; Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 9120001, 9120004, 9120005, 9120008, 9120009 and 9121009 The Maxi Sky 1000 is designed for lifting patients in a homecare setting, at nursing homes and other assisted living centers, as well as in institutional or hospital settings. Patient transferring is performed under the supervision of an appropriately trained caregiver staff, in accordance with the instructions for use. All other uses must be avoided.

    Recall: Z-1983-2011 · Initiated March 21, 2011

    Recall

    Recall Number
    Z-1983-2011
    Event Number
    58048
    Firm
    Arjo, Inc. dba ArjoHuntleigh
    FEI Number
    1419652
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 21, 2011
    Posted
    April 14, 2011
    Terminated
    February 16, 2012
    Address
    2349 W Lake St, Addison, IL, 60101-6183

    Description

    Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift; ArjoHuntleigh, Addison, IL 60101; Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 9120001, 9120004, 9120005, 9120008, 9120009 and 9121009 The Maxi Sky 1000 is designed for lifting patients in a homecare setting, at nursing homes and other assisted living centers, as well as in institutional or hospital settings. Patient transferring is performed under the supervision of an appropriately trained caregiver staff, in accordance with the instructions for use. All other uses must be avoided.

    Reason

    The battery-powered control board in the ceiling lift motor may overheat, resulting in smoke and possibly flames and the lift becoming inoperable.

    Action

    ArjoHuntleigh sent an Urgent Field Safety Notice dated March 4, 2011, to all affected customers via UPS Ground on March 21, 2011. The notice informed the accounts of the potential for smoke and flames coming out of the Maxi Sky 1000/V10 bariatric ceiling lifts. The accounts were requested to immediately cease use of the affected lifts, powering them down by activating the emergency stop, and tag the lifts to prevent further use. If there is a clinical need to continue use of the lift before it is retrofitted or replaced, specific instructions were given to reduce the risk of a device malfunction. The accounts were requested to complete the Customer Response Form online, using the enclosed card's instructions. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 57985.

    Distribution

    Nationwide Distribution

    Quantity

    1,246 units