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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 017 06 13 000
Date submitted: 6/4/2013
Manufacturer:Varian Medical Systems
Device Type:Radiotherapy Systems, High-Energy C-Series Clinac Linear Accelerators
Description: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
Remedy Action: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.
Athorized Representative/Importer/Distributor:Varian Medical Systems , Riyadh , +966 11 2772126
Report Source:NCMDR
Source Ref. Number:A3B54EBABC31C
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian.pdf