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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 084 06 11 000
Date submitted: 6/22/2011
Manufacturer:Varian Medical Systems
Device Type:Optical Guidance Platforms
Description:Software, Radiotherapy System, Linear Accelerator
Medical Device Identifier:Software Version 2.6, 2.6.1 Serial numbers are Attached
Reason of Field Safety Corrective Action:The Optical Guidance Platform (OGP) camera calibration is not designed or validated for durations longer than 24 hours. The OGP requires recalibration on a daily basis to ensure that the optical calibration is correct for proper patient alignment and monitoring before use in treatment.
Remedy Action:The manufacturer has issued a Field Safety Notice to make users aware of the problem and to inform them how to reset the Optical Guidance Camera calibration and that they have made changes to the Optical Guidance Platform Instructions for Use. In addition the manufacturer is preparing a software patch which will be applied to affected units to further mitigate this condition.
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh, (01) 2772126
Report Source:NCAR
Source Ref. Number:UK-2011-06-20-083
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: UK-2011-06-20-083_CP-03976-PNL-FSN-ENG2-A.pdf