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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 049 11 11 000
Date submitted: 11/11/2011
Manufacturer:Varian Medical Systems
Device Type:COMPUTER TREATMENT PLANNING
Description:Radiotherapy Systems, Linear Accelerator
Medical Device Identifier:ARIA RT Chart Application v8.0 and 8.1
Reason of Field Safety Corrective Action:If the user selects the “Convert to Setup Field” option when using the RT Chart function in ARIA (versions 8.0 and 8.1), the Dynamic Multi Leaf Collimator (DMLC) plan components are removed in order to create an open collimator for field light setup. In the reported case (CP-03045 from the USA) a user selected this option in error and then converted the Set-up field back to a Treatment field. The DMLC was then missing from the resultant treatment field. If this error is not detected prior to patient treatment an open field treatment can result.
Remedy Action:The manufacturer has issued a FSN to warn users of this problem and how to avoid it.
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh, (01) 2772126
Report Source:NCAR
Source Ref. Number:UK-2011-11-04-141
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments