BEUDAMED
    FDA Enforcement Class II Terminated

    MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.

    Recall: Z-1663-2014 · Reported June 4, 2014

    Enforcement

    Recall Number
    Z-1663-2014
    Event ID
    68221
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 4, 2014
    Initiation Date
    April 24, 2014
    Classification Date
    May 27, 2014
    Termination Date
    January 8, 2015
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355, United States

    Description

    MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.

    Reason

    Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.

    Code Info

    model # 10432914 with serial numbers: 52126 52135 52108 52025 52101

    Distribution

    Distributed in the states of MN, CA, CO, TX, and IA.

    Quantity

    5