BEUDAMED
    FDA Recall Terminated

    MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.

    Recall: Z-1505-2014 · Initiated February 13, 2014

    Recall

    Recall Number
    Z-1505-2014
    Event Number
    67568
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    February 13, 2014
    Posted
    April 24, 2014
    Terminated
    March 16, 2015
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    Description

    MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.

    Reason

    It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose. According to the Installation Instructions the corrugated hose holder shall be afixed with transversal carriage, with Loctite 243 and Torque 10nm during system installation. Siemens initiated the update instruction to verify and secure the hose holder with Loctite 243. A PCB D802 Rev. 00 b

    Action

    Affected customers were initially notified with a recall letter on/about 2/12/14 and were sent Update Instructions to affected customers.

    Distribution

    Distributed in the states of AK, PA, KY, OH, WI, MI, FL, and NY.

    Quantity

    12