Your changes have been successfully saved
Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 017 06 13 000
Varian Medical Systems
Radiotherapy Systems, High-Energy C-Series Clinac Linear Accelerators
Radiotherapy Systems, Linear Accelerator
Medical Device Identifier:
(1) Clinac (2) Novalis Tx (3) Trilogy (4) Trilogy Tx Product Nos.: (1 through 4) H14, H26, H27, H29, HCX
Reason of Field Safety Corrective Action:
May Deliver a Photon Beam with Symmetry outside Varian Beam Specifications
Identify any affected product in your inventory. Varian recommends that users verify photon beam symmetry or profile constancy monthly. Varian states that this recommendation follows typical guidance provided by the AAPM in its TG-40 and TG-142 documents and others. Varian states that, following a previous problem with undetected electron beam asymmetry, it has developed new dosimetry circuitry to detect certain beam asymmetry conditions, which will also detect the photon beam asymmetry associated with this problem. Varian also states that this modification has been developed for HE Clinacs built using the current electronics architecture, representing a large majority of HE Clinacs in use. your local service office will contact your facility to arrange to install this modification.
Varian Medical Systems , Riyadh , +966 11 2772126
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.