BEUDAMED
    FDA Recall 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 · Initiated April 24, 2014

    Recall

    Recall Number
    Z-1663-2014
    Event Number
    68221
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    April 24, 2014
    Posted
    May 27, 2014
    Terminated
    January 8, 2015
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355

    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.

    Action

    A customer safety advisory notice, dated April 24, 2014 was sent to notify direct accounts of the delivery of user manuals.

    Distribution

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

    Quantity

    5