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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 078 12 13 000
Varian Medical Systems
Eclipse™ Treatment Planning System, ARIA® for Radiation Oncology, ARIA® Radiation Therapy Management, and Acuity™
Treatment Planning System
Medical Device Identifier:
Versions 11 and 13
Reason of Field Safety Corrective Action:
The Plan Parameters workspace within Eclipse™ Treatment Planning System, ARIA® Radiation Oncology, ARIA® Radiation Therapy Management, and Acuity™. When a dose relevant parameter is changed and “Do not clear MUs and Reference Point dose” is selected, the Monitor Units (MUs) may change.
DO NOT USE the Plan Parameters workspace to modify 3D Treatment Plans containing a 3D dose. When it is necessary to edit patient treatment plans containing 3D dose, this action must be performed in Eclipse™ External Beam Planning or in your applicable treatment planning system.
Varian Medical Systems recommends a thorough review of treated patient plans for plans with a primary reference point with geometric location and where modifications were made in the Plan Parameter workspace.
Varian Medical Systems is developing a technical correction for this issue. You will be contacted by a Customer Support representative when this correction is available to schedule its installation on your system.
Varian Medical Systems, (011) 2772126
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
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