BEUDAMED
    FDA Recall Terminated

    MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.

    Recall: Z-1308-2015 · Initiated March 9, 2015

    Recall

    Recall Number
    Z-1308-2015
    Event Number
    70712
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 9, 2015
    Posted
    March 20, 2015
    Terminated
    August 17, 2016
    Address
    51 Valley Stream Pkwy, Malvern, PA, 19355-1406

    Description

    MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.

    Reason

    The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur.

    Action

    A Customer Safety Advisory Notice, dated March 6, 2015, was sent to end users to inform them of the potential issue and what measures were being taken to mitigate possible risks.

    Distribution

    Nationwide Distribution.

    Quantity

    132