BEUDAMED
    FDA Recall Terminated

    Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.

    Recall: Z-0326-2017 · Initiated August 9, 2016

    Recall

    Recall Number
    Z-0326-2017
    Event Number
    75197
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    August 9, 2016
    Posted
    October 31, 2016
    Terminated
    March 24, 2017
    Address
    1069 State Road 46 E, Batesville, IN, 47006-7520

    Description

    Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.

    Reason

    Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if the Ceiling Bracket 71 with a larger center hole is used for a concrete ceiling Ultra System installation with the M8 screw and the safe working load is exceeded, the system could fall.

    Action

    On 8/9/2016, URGENT: MEDICAL DEVICE CORRECTION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this Field Safety Correction, please contact Hill-Rom Technical Support at 1-800-445-3720, your distributor or your Hill-Rom representative.

    Distribution

    WA NC OH PA MI Australia Sweden

    Quantity

    188