BEUDAMED
    FDA Enforcement Class II Terminated

    OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798; OR Table Top U14 H V, Model # 1909799 Product Usage: Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Patient transport on the operating table top from a patient transfer system to the operating theater or from the operating theater to a patient transfer system.

    Recall: Z-0391-2017 · Reported November 16, 2016

    Enforcement

    Recall Number
    Z-0391-2017
    Event ID
    75412
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trumpf Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 16, 2016
    Initiation Date
    October 25, 2016
    Classification Date
    November 9, 2016
    Termination Date
    February 6, 2017
    Address
    1046 Legrand Blvd, Charleston, SC, 29492-7672, United States

    Description

    OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798; OR Table Top U14 H V, Model # 1909799 Product Usage: Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Patient transport on the operating table top from a patient transfer system to the operating theater or from the operating theater to a patient transfer system.

    Reason

    Trumpf has identified six incidents of pinched cables.

    Code Info

    Model # 190973 - Serial Number Range 102394262 - 102974610; Model # 1909794 - 102884276; Model # 1909796 - 102440024 - 102981676; Model # 1909797 - 102757564 - 102958935; Model # 1909798 - 102831498 - 102831519; Model # 1909799 - 102393683 - 102969656

    Distribution

    Worldwide Distribution - US Nationwide in the states of AZ and SC and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Iceland, Italy, Norway, Qatar, Slovenia, Spain, Sweden, Switzerland

    Quantity

    4 (US) & 229 (Foreign)