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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 050 11 11 000
Date submitted: 11/11/2011
Manufacturer:BrainLAB
Device Type:BrainSCAN ,Pencil Beam Dose Algorithm
Description:Beam Dose Algorithm
Medical Device Identifier:Versions 5.31 and 5.32
Reason of Field Safety Corrective Action:The BrainSCAN Pencil Beam Dose Algorithm may overestimate the dose delivered to the target region if both of the following conditions are met: - The scatter measurements have been performed according to the Technical Reference Guide (TRG) “Brainlab Physics” (any revision), i.e. the scatter table was measured and implemented without values for equal jaw and MLC field sizes. AND - In the treatment plan, the margin between jaw position and MLC field shape is set to a value smaller than the default margin of 8mm in leaf movement direction and 2mm in direction perpendicular to leaf movement
Remedy Action:In the scatter table of your implemented dose data for BrainSCAN version 5.3.1 or 5.3.2: Make sure that, for each jaw field size (column), there is one identical MLC square field size (row).(Attached)
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119999
Report Source:NCMDR
Source Ref. Number:B80A09583715A
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: BrainLAB.pdf