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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 033 01 11 000
Date submitted: 1/17/2011
Manufacturer:GE Medical Systems.
Device Type:Advantage Sim MD.
Description:Software for X-ray system, used for radiotherapy.
Medical Device Identifier:Software version: 5.x, 6.x, 7.x
Reason of Field Safety Corrective Action:1. When using the Center on Cursor feature in combination with a blended DRR in certain AdvantageSim versions, the captured DRR will remain fixed in the original position while the active DRR will move to a position where the 3D cursor is centered on the screen. 2. When using the Isocenter Move mode feature in combination with a blended DRR in certain AdvantageSim versions, the captured DRR will remain fixed in the original position while the active DRR is correctly recalculated and shown. 3. When the image series is changed (on the top left corner of a DRR view) while using DRR blending, the captured DRR is not recalculated or cancelled. 4. When using the blended DRR function the visualization of the captured DRR may change without the visualization parameters (MIXING and DEPTH CONTROL) being updated on-screen after choosing a DRR preset for the active DRR. 5. When a new beam is created after using DRR blending on a previous beam, switching back to the previous beam may cause annotations for BLENDING, MIXING and DEPTH CONTROL to not be shown.
Remedy Action:Safety issues 1-3 and 5 can be corrected by turning the DRR “off” and then back “on” to force it to recalculate and display correctly. Safety issue 4 requires manual setting of the DRR parameters instead of using a preset. Please see Attached files for detailed instructions for each safety issue.
Athorized Representative/Importer/Distributor:GE Healthcare., Riyadh, (01) 4600530
Report Source:http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
Source Ref. Number:FR-2010-12-24-053
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: FR-2010-12-24-053 Annex FSN.pdf