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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 068 07 11 000
Date submitted: 7/18/2011
Manufacturer:TomoTherapy Incorporated
Device Type:Hi-Art DICOM System
Description:Radiotherapy: treatment planning system.
Medical Device Identifier:Hi·Art versions 4.0.x, and HD versions 1.0.x
Reason of Field Safety Corrective Action:During DICOM export of plan level images with a non square exported Field of View (FOV), an anomaly in the process of squaring the plan level image may cause the image to shift with respect to ROIs and dose. When the anomaly occurs, the magnitude of the image shift can be a full IEC-X voxel, a full IEC-Z voxel, or full voxels in both IEC-X and IEC-Z.
Remedy Action:After DICOM export of images with non square FOV; carefully review the image / ROI / dose relationship for shifts. To determine whether a subsequent DICOM export could be affected, review the number of coronal and sagittal slices on the fractionation tab. If the total number of slices differs between the two planes, the image is not square and the DICOM export of the plan level image could be affected by this issue. This issue will be remedied with Hi·Art software version 4.1 and HD software version 1.1 and later.
Athorized Representative/Importer/Distributor:Gulf Medical Co. Jeddah (02) 6512828
Report Source:NCMDR
Source Ref. Number:A9D128BAD032C
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Tomotherapy.pdf