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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 109 06 13 000
Date submitted: 6/23/2013
Manufacturer:Elekta Limited
Device Type:Therapeutic Radiation System, Digital Accelerator
Description:Precise Treatment System
Medical Device Identifier:All Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2, Agility or Asymmetric Heads
Reason of Field Safety Corrective Action:Some Digital Accelerators have increased electron applicator auto-tracking settings in the field, to values greater than the factory-set defaults. Increasing auto-tracking values from factory-set defaults goes against Elekta recommendations and can result in the system becoming non-compliant with IEC standards, in particular with the safety standard IEC 60601-2-1
Remedy Action:Please adhere to the instructions and advice given in manuals and system dialogues, which explicitly state that a change to auto-tracking values could compromise compliance with safety standards and can cause increased unwanted radiation dose to the patient ( More details in attached file ).
Athorized Representative/Importer/Distributor:Analysis Device for Medical Service and Scientific, Dammam, (03) 8174422
Report Source:NCMDR
Source Ref. Number:415D8E9374233
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Elekta.pdf