BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.

    Recall: Z-1985-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1985-2014
    Event ID
    68382
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2014
    Initiation Date
    May 9, 2014
    Classification Date
    July 2, 2014
    Termination Date
    December 15, 2014
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355, United States

    Description

    Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.

    Reason

    There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the original manufacturing or as spare parts between October 2010 and April 2011 for the Siemens Mobilett XP Digital mobile X-ray System, which might occur at any time with higher probability while the system is being charged and connected to the main power supply.

    Code Info

    model no. 1818447, with serial nos.: 3284 3449 1026 1025 1010 1041 1054 2002 2058 2022

    Distribution

    US Nationwide Distributions in the states of MO, GA, FL, NJ, CA, PA and including NM.

    Quantity

    10