BEUDAMED
    FDA Enforcement Class III Terminated

    Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.

    Recall: Z-2133-2014 · Reported August 6, 2014

    Enforcement

    Recall Number
    Z-2133-2014
    Event ID
    68400
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2014
    Initiation Date
    May 27, 2014
    Classification Date
    July 30, 2014
    Termination Date
    December 15, 2014
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.

    Reason

    There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.

    Code Info

    DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332 DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, 224719-AX

    Distribution

    FL LA AR IA OH OH WI IL LA KS MT

    Quantity

    15