X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 121 02 12 000
Date submitted: 2/19/2012
Manufacturer:Varian Medical Systems
Device Type:Varian Clinac® accelerators with Mark or Millennium MLC and BrainLAB m3 MLC
Description: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.
Remedy Action: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.
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh, (01) 2772126
Report Source:NCMDR
Source Ref. Number:AE152DA2E7279
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian Medical Systems.pdf