SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCMDR Recall

Back

Reference Number:	mdprc 066 08 11 000
Date submitted:	8/22/2011

Manufacturer:	Varian Medical Systems
Device Type:	4D Integrated Treatment Console
Description:	Radiology information system (4DITC).
Medical Device Identifier:	4D ITC versions 8.1 SP2 to 10.0 SP1. See attachment for Serial numbers
Reason of Field Safety Corrective Action:	The 4D Integrated Treatment Console (4DITC) is scheduled for a mandatory upgrade from your current version to 10.2. The reason for the upgrade is to ensure customers have the most current version of 4DITC which contains several improvements to address issues related to proper recording of treatment information from Varian machines.
Remedy Action:	Varian is notifying all affected customers with this document. Varian will issue a customer technical bulletin to inform users of the mandatory upgrade and related information.
Athorized Representative/Importer/Distributor:	Varian Medical Systems, Riyadh (01) 2772126
Report Source:	NCMDR
Source Ref. Number:	8515154D5114D
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments:	4D.pdf

View History