BEUDAMED
    FDA Enforcement Class II Terminated

    MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light

    Recall: Z-0515-2013 · Reported December 19, 2012

    Enforcement

    Recall Number
    Z-0515-2013
    Event ID
    63496
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 19, 2012
    Initiation Date
    October 10, 2012
    Classification Date
    December 12, 2012
    Termination Date
    November 6, 2014
    Address
    51 Valley Stream Pkwy, N/A, Malvern, PA, 19355, United States

    Description

    MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light

    Reason

    A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems.

    Code Info

    Part numbers 7721165, 4787714, 7559375, 10281150, 10281151, 10281152 and 10281183

    Distribution

    Nationwide Distribution

    Quantity

    1315