BEUDAMED
    FDA Recall 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 · Initiated October 25, 2016

    Recall

    Recall Number
    Z-0391-2017
    Event Number
    75412
    Firm
    Trumpf Medical Systems, Inc.
    FEI Number
    3003184737
    Product Code
    JEA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 25, 2016
    Posted
    November 10, 2016
    Terminated
    February 6, 2017
    Address
    1046 Legrand Blvd, Charleston, SC, 29492-7672

    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.

    Action

    Trumpf Medical sent an Urgent Medical Device Correction letter dated October 7, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken The letter indicated that a authorized service provider will inspect the table tops and make necessary corrections. A confirmation notice was included with the letter which is to be returned. For contact Trupmpf Medical Systems, Inc. at 888-474-9359.

    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)