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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 121 02 12 000
Varian Medical Systems
Varian Clinac® accelerators with Mark or Millennium MLC and BrainLAB m3 MLC
Accelerator System, Linear,
Medical Device Identifier:
(Serial Numbers Attached)
Reason of Field Safety Corrective Action:
A possibility of a Varian MLC interfering with the treatment field of a demountable BrainLAB m3 micro-MLC without an interlock being asserted.
Action to be done by the user: Prior to installing a BrainLAB m3 MLC, and switching the communication and interlock paths from the Varian MLC controller to the BrainLAB m3 MLC controller the user MUST verify the Varian MLC leaves are parked and not interfering with the BrainLAB m3 treatment field. Varian will contact customers to arrange upgrade installation.
Varian Medical Systems, Riyadh, (01) 2772126
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Varian Medical Systems.pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.