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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 127 06 12 000
Date submitted: 6/24/2012
Manufacturer:BrainLAB
Device Type:Planning software, iPlan RT Dose version 4.1
Description:iPlan RT Dose.
Medical Device Identifier:version 4.1 only (v. 4.1.0, 4.1.1 and 4.1.2)
Reason of Field Safety Corrective Action:If all of the conditions listed in (Effect section in the attached file) are met. The isocenter positions and the RT structures exported from iPlan RT Dose version 4.1 might be incorrect. If not recognized by the user, an incorrect patient position for irradiation might result.
Remedy Action:Brainlab will provide a software update with this issue solved to affected customers. Tentative planned timeline for availability: End of 2012. (find attached for User action)
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01)2119948
Report Source:NCMDR
Source Ref. Number:491A327932140
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: BrainLAB.pdf