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 055 12 18 000
Date submitted:	12/13/2018

Manufacturer:	Elekta Inc.
Device Type:	MOSAIQ Radiation Oncology
Description:	Radiology information system
Medical Device Identifier:	MOSAIQ Radiation Oncology customers using release version 1.0 and higher and Multi-ACCESS Customers using release version 6.1 and higher.
Reason of Field Safety Corrective Action:	If there are no Wedge IDs included in the DICOM RT PLAN sent from the TPS, the field in MOSAIQ will be created with no wedge.
Remedy Action:	Review your TPS system to verify that Wedge IDs are defined for all wedges. Also, check to make sure that the exported RT Plan information contains the necessary Wedge IDs.
Athorized Representative/Importer/Distributor:	Medical Regulations Gate
Report Source:	NCMDR
Source Ref. Number:	39595B19CD1D3
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Elekta.pdf

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