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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 013 07 14 000
Date submitted: 7/3/2014
Manufacturer:Varian Medical Systems
Device Type:C-Series High Energy Linear Accelerators
Description:Radiotherapy Systems, Linear Accelerator
Medical Device Identifier:- C-Series High Energy Linear Accelerator
- Affected Version(s) / Lot(s): Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac CX, Clinac 2100 C/D, Clinac 2300C/D, Clinac DX, Clinac 21 EX, Clinac 23 EX
- 6MV configurations only
Reason of Field Safety Corrective Action:May Exhibit Unexpected 6MV Beam Output Variations
Remedy Action:Identify any affected product in your inventory. Varian recommends that your facility implement daily output constancy checks of photon beams as recommended by the AAPM, specifically those provided by the following:

(1) AAPM, Task Group 142 Report: Quality Assurance of Medical Accelerators, Medical Physics publication 36 (9), September 2009.

(2) AAPM Report No. 46, Comprehensive QA for Radiation Oncology, Report of Task Group No. 40 Radiation Therapy Committee, April 1994.

Varian states that it is particularly important that these daily output constancy checks include all 6MV beams (6SRS, 6FFF, and 6X) and that your facility should particularly check for any sudden decreases in dose output ≥3% per day, or ≥6% per week. Measurements should be made with buildup (5 cm water equivalent) that is beyond the electron range to avoid electron contamination of measurements. If any sudden decrease in dose output is observed, stop using all 6MV beams and immediately contact Varian. A Varian service representative will then visit your facility to investigate whether the target is degrading or has failed. Varian recommends that a service call be requested in the even system faults are generated for target cooling to investigate and determine whether a cooling circulation problem exists.
Athorized Representative/Importer/Distributor:Varian Medical Systems, (011) 2772126
Report Source:NCMDR
Source Ref. Number:CD32F9C4D8394
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian Medical Systems.pdf