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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 078 12 13 000
Date submitted: 12/9/2013
Manufacturer:Varian Medical Systems
Device Type:Eclipse™ Treatment Planning System, ARIA® for Radiation Oncology, ARIA® Radiation Therapy Management, and Acuity™
Description: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.
Remedy Action: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.

Athorized Representative/Importer/Distributor:Varian Medical Systems, (011) 2772126
Report Source:NCMDR
Source Ref. Number:4CC1A4C5A0316
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: varian.pdf