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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 012 01 11 000
Date submitted: 1/8/2011
Manufacturer:Varian Medical Systems
Device Type:Radiotherapy, 4D Integrated Treatment Console
Description:Radiotherapy, planning, simulators: computer treatment planning
Medical Device Identifier:4DITC all versions up to and including 8.8.17. For affected devices, See attached list
Reason of Field Safety Corrective Action:This advisory notice is to provide you with updated information on multi-isocenter plan management and acquisition of couch parameters for multi-isocenter plans at the 4DITC.
Remedy Action:Recommended User Action 1- Varian recommends that users use caution when acquiring actual couch positions for any plan.2- Varian recommends that each plan be reviewed for quality assurance purposes in accordance to set departmental or organizational policies. 3- Multiple plans within the same course would be the preferred method to accomplish this goal. 4- Varian recommends that the digital graticule be turned on when evaluating any image 5- If you are unsure how to proceed, please contact the Varian HelpDesk for advice. Worldwide e-mail addresses are listed on the attached file as well as internet support. Varian Actions: 1- Varian is notifying all affected customers with this document. 2-Varian has also chosen to update the procedure described in CTB-TR-735 to inform users of the behavior acquiring couch parameters for multi-isocenter plans. 3- The ability to handle multiple isocenter plans will be introduced with 4DITC version 10.
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh (01) 2772126
Report Source:NCMDR, MHRA
Source Ref. Number:16B5C8B6BF308
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Varian.pdf