BEUDAMED
    FDA Recall Terminated

    GE Healthcare, Discovery MR450 Product Usage: The Discovery MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/ or functions of the entire body including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra, when interpreted by a trained physician yield information that may assist in diagnosis.

    Recall: Z-3123-2011 · Initiated July 29, 2011

    Recall

    Recall Number
    Z-3123-2011
    Event Number
    59232
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 29, 2011
    Posted
    September 1, 2011
    Terminated
    August 7, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, Discovery MR450 Product Usage: The Discovery MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/ or functions of the entire body including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra, when interpreted by a trained physician yield information that may assist in diagnosis.

    Reason

    GE Healthcare has become aware of two potential safety issues associated with MR products (Optima MR450w, Discovery MR450, Discovery MR750, Brivo MR355, Optima MR360) that may impact patient safety. 1) Inline post-processed (i.e. automated post-processing) image locations are not correctly annotated under some conditions. 2) Reference images displayed in Functool FiberTrak do not match with

    Action

    GE Healthcare sent an "Urgent Medical Device Correction" letter dated July 27, 2011 to customers with affected systems. The letter described the recalled product, safety issues and recommended actions to be taken. The letter provided immediate mitigation (Safety Instuctions) that address each issue. The letter states that the recalling firm will contact customers to arrange to provide a software upgrade to all affected systems at no cost. For any questions concerning this notification contact your local service representative.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of: AL, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, LA,ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WT, WY. and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CROAT IA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KUWAIT, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, REPUBLIC OF KOREA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUKEYand UNITED KINGDOM.

    Quantity

    55