BEUDAMED
    FDA Enforcement Class II Terminated

    AXIOM Vertix MD Trauma systems radiographic X-ray

    Recall: Z-1460-2014 · Reported April 23, 2014

    Enforcement

    Recall Number
    Z-1460-2014
    Event ID
    67780
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 23, 2014
    Initiation Date
    March 5, 2014
    Classification Date
    April 16, 2014
    Termination Date
    March 16, 2015
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    AXIOM Vertix MD Trauma systems radiographic X-ray

    Reason

    There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. In rare cases, steel ropes inside the lift column of the system can be defective without triggering the safety lock, which can result in the U-arm dropping down unexpectedly during movement in vertical direction, potentially causing serious injury.

    Code Info

    AXIOM Vertix MD Trauma systems (material no. 08908290) with serial numbers 1022 through 1058.

    Distribution

    US Distribution including MO and OH.

    Quantity

    2