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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 033 04 13 000
Date submitted: 4/9/2013
Manufacturer:BrainLAB
Device Type:Stereotactic Systems, Image-Guided, Radiosurgical, Linear Accelerator, ExacTrac 5.x Patient Positioning System
Description:Stereotactic Systems, Image-Guided, Radiosurgical, Linear Accelerator.
Medical Device Identifier:Product Reference: ExacTrac versions 5.0, 5.0.1 and 5.0.2; ExacTrac versions 5.5, 5.5.1 and 5.5.2
Reason of Field Safety Corrective Action:BrainLAB are writing to advise you of an anomaly detected in ExacTrac 5.x when used in combination with a non-Brainlab radiation treatment planning system (TPS). This anomaly can mislead the user when selecting a treatment plan / isocenter (radiation treatment target) in ExacTrac for patient positioning at the linear accelerator (linac).
Remedy Action:When using the Brainlab ExacTrac 5.x patient positioning system in combination with a non-Brainlab treatment planning system, always select the following options during a plan import into ExacTrac (see attached). Brainlab will provide a software update with this issue solved to affected customers.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:CDE01AF396350
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: BrainLAB.pdf