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 065 12 16 000
Date submitted: 12/14/2016
Manufacturer:BrainLAB
Device Type:iPlan RT and iPlan RT Dose , BrainSCAN
Description:Software, Workstation Management, Radiotherapy Planning
Medical Device Identifier:iPlan RT and iPlan RT Dose (all versions), BrainSCAN (discontinued)
Reason of Field Safety Corrective Action:Potential inaccurate dose calculation for small MLC-shaped fields when using the Pencil Beam algorithm
Remedy Action:1) Brainlab provides existing potentially affected customers with this product notification information.
2) Brainlab will provide a software solution (iPlan RT) to prevent the described scenario from occurring. Brainlab will actively contact affected customers tentatively starting September 2017 to schedule the update.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:2AE0D376522A5
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: BrainLAB.pdf