BEUDAMED
    FDA Recall Terminated

    GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system

    Recall: Z-1148-2014 · Initiated March 25, 2011

    Recall

    Recall Number
    Z-1148-2014
    Event Number
    66119
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 25, 2011
    Posted
    March 6, 2014
    Terminated
    March 13, 2014
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system

    Reason

    When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM header does not change to reflect the new image, thus the line measurements may be inaccurate.

    Action

    No consignee letter was sent out. FMI No. 25431 shows where the Field Engineer had to communicate with the hospital (Instead of them sending a letter). GE Healthcare has updated all of the affected Advantage Workstation systems affected by the GSI viewer issue. At this time, deployment of the recall is considered complete. As an effectiveness check, they have tracked all service requests for the field action to completion. These service requests record the repair of the affected units. Exceptions to completion of the service request have been recorded as well. Records of field action completion will be retained per their processes and procedures.

    Distribution

    Worldwide Distribution: US (nationwide): AL, AZ, CA, CT, FL, IL, IN, IA, KY, MD, MA, MI, MS, NV, NH, NJ, NY, PA, WA, and WI; and countries of: AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KUWAIT, LATVIA, NEW ZEALAND, POLAND, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWEDEN,, SWITZERLAND, TAIWAN, and UNITED KINGDOM.

    Quantity

    283 (59 US, 224 OUS)