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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 093 08 18 000
Date submitted: 8/29/2018
Manufacturer:Varian Medical Systems
Device Type:TrueBeam, TrueBeam STx, VitalBeam and EDGE treatment delivery systems
Description:Software, Stereotactic System, Frame-Guided, Radiosurgery
Medical Device Identifier:Version: 2.0 and 2.5 [<2.5MR2]
Reason of Field Safety Corrective Action:Varian Medical Systems has received reports of an anomaly that can result in a treatment without intended gating. This issue occurs when a patient planned with gating is treated on more than one TrueBeam system [includes: TrueBeam, TrueBeam STx, VitalBeam or EDGE]. Varian has not received any reports of injury due to this issue. The issue only affects TrueBeam systems version 2.0, 2.5 and 2.5 MR1.
Remedy Action:For treatment plans with intended gating, Varian recommends users monitor and pay attention to the system status message. When a patient with a gated treatment plan is moved to a second TrueBeam system, users must verify that intending gating was not overridden.
If gating is overridden, users should reselect it from the Tools menu. Contact Varian Support if you have questions regarding selecting gating from the Tools menu.
Varian Medical Systems is investigating a solution for this issue. You will be contacted by a Customer Service Representative to schedule upgrade to the correction when available.
Athorized Representative/Importer/Distributor:Varian Medical Systems Arabia Commercial Limited
Report Source:NCMDR
Source Ref. Number:5EB542F51325D
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian Medical Systems.pdf