BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system

    Recall: Z-1848-2013 · Reported August 7, 2013

    Enforcement

    Recall Number
    Z-1848-2013
    Event ID
    65491
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 7, 2013
    Initiation Date
    May 7, 2013
    Classification Date
    August 1, 2013
    Termination Date
    December 24, 2013
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system

    Reason

    Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. Four consignees were notified of this recall by Update Instruction XP067/12/S -- all four units have been corrected.

    Code Info

    Model number 10094200, serial numbers 4024, 4077, 4043 and 4051

    Distribution

    US Distribution including the states of CA, IN, NJ and OK.

    Quantity

    4