SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 091 11 11 000
Date submitted:	11/27/2011

Manufacturer:	Varian Medical Systems
Device Type:	Radiation Therapy, Eclipse with ARIA™ Radiation Oncology (RT Chart module)
Description:	Radiation Therapy, treatment planning system
Medical Device Identifier:	Eclipse Release 10 with ARIA™ Radiation Oncology (RT Chart module) Release 10 (Client Build 10.0.28 or Build 10.0.34). Serial numbers list attached.
Reason of Field Safety Corrective Action:	An anomaly has been identified within Varian Eclipse™ when used with ARIA™ Radiation Oncology (RT Chart module) where adding a reference point in RT Chart and editing the field dose contributions may change the Prescribed Dose Per Fraction in Eclipse.
Remedy Action:	Varian will be notifying all affected customers with a letter. This issue has been corrected in a maintenance release (10MR2, Client Build 10.0.39) of Eclipse and ARIA RT Chart. All affected customers will be contacted by Varian to schedule installation.
Athorized Representative/Importer/Distributor:	Varian Medical Systems, Riyadh, (01) 2772126
Report Source:	NCMDR
Source Ref. Number:	2B8A6FE5982A1
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Varian Medical Systems.pdf

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