BEUDAMED
    FDA Enforcement Class II Terminated

    Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.

    Recall: Z-0047-2018 · Reported November 1, 2017

    Enforcement

    Recall Number
    Z-0047-2018
    Event ID
    78086
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 1, 2017
    Initiation Date
    September 18, 2017
    Classification Date
    October 25, 2017
    Termination Date
    December 11, 2017
    Address
    2501 Barrington Rd, N/A, Hoffman Estates, IL, 60192-2061, United States

    Description

    Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.

    Reason

    The torque wrench used to tighten system bolts during installation was found to be out of tolerance

    Code Info

    Symbia T2 serial number 2001; Symbia Intevo Excel serial numbers 2112 and 2140; Symbia Intevo 16 serial numbers 2100 and 2116; Symbia Evo serial numbers 1049, 1054, 1071, 1075, 1104, and 1128; and Symbia Evo Excel serial numbers 1109, 1111, 1131, 1134, and 1158.

    Distribution

    Distribution was made to medical facilities located in CA, FL, GA, LA, NY, PA, and TN. There was government distribution but no foreign/military distribution.

    Quantity

    16 devices