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 036 01 19 000
Date submitted:	1/14/2019

Manufacturer:	Varian Medical Systems
Device Type:	ARIA Oncology Information System for Radiation Oncology
Description:	Radiation Oncology
Medical Device Identifier:	Affected Version(s) / Lot(s): 15.1, 15.5, 15.6
Reason of Field Safety Corrective Action:	Varian Medical Systems has identified a problem in ARIA Oncology Information System (OIS) for Radiation Oncology such that a user may inadvertently chart medical record information in an unintended patient’s chart.
Remedy Action:	-Varian recommends that Users close each patient prior to opening a new one. This will prevent this issue from occurring. -Varian Medical Systems is investigating this issue. The timeline of a technical solution is currently unknown. Varian will contact users as a fix is available.
Athorized Representative/Importer/Distributor:	Varian Medical Systems Arabia Commercial Limited
Report Source:	NCMDR
Source Ref. Number:	138B3678601AC
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Varian Medical Systems.pdf

View History