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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 038 08 17 000
Date submitted: 8/15/2017
Manufacturer:Nucletron bv
Device Type:Oncentra® Brachy
Description:Comprehensive treatment planning software
Medical Device Identifier:Sites affected will be those running Oncentra Brachy versions 4.5, 4.5.1, 4.5.2.
Reason of Field Safety Corrective Action:Incorrect source step size may occur in Oncentra Brachy plans for Ring or Venezia applicator models with microSelectron.
Remedy Action:The problem will be resolved in a software upgrade to Oncentre Brachy 4.5. The fix is currently being developed and is estimated to released by the end of February 2018. The target time for completion is 12 months from date solution is made available.
Athorized Representative/Importer/Distributor:The problem will be resolved in a software upgrade to Oncentre Brachy 4.5. The fix is currently being developed and is estimated to released by the end of February 2018. The target time for completion is 12 months from date solution is made available.
Report Source:NCMDR
Source Ref. Number:0EE95B565F207
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Nucletron B.V..pdf