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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 019 07 12 000
Date submitted: 7/8/2012
Manufacturer:Varian Medical Systems
Device Type:Radiation Therapy, Eclipse Treatment Planning System
Description:Radiation Therapy
Medical Device Identifier:Versions 8.5,8.6,8.9, 10, and 11
Reason of Field Safety Corrective Action:If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization, the Monitor Units and dose distribution may not reflect the intended prescription. Affects Eclipse v8.5 to v11.
Remedy Action:It is not recommended to change prescription after the dose volume optimization has been performed. If changes are made, the plans must be re-optimized and visualized. When using VMAT or RapidArc optimization: -Always verify the final plan using DVH analysis inside Eclipse when approving plans or plan sums for treatment. -Evaluate dose distribution visually. -Verify the maximum dose and its location inside the irradiated target after dose calculation. -Always follow warnings, cautions and messages provided by the software. Varian Medical Systems is developing a technical correction for this issue. You will be contacted by a Customer Service rep when this correction is available to schedule its installation on your system.
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh, (01) 2772126
Report Source:NCMDR
Source Ref. Number:2C45FA7642223
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian.pdf