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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 146 03 14 000
Date submitted: 3/31/2014
Manufacturer:Varian Medical Systems
Device Type:On-Board Imager
Description:On-board imaging (OBI) refers to the use of daily x-rays (taken right on the linear accelerator) that help to confirm a match of treatment setup to the planned treatment.
Medical Device Identifier:Type 01 Elbow Motors
Reason of Field Safety Corrective Action:The shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager® [OBI] device have failed due to belt over-tensioning. This over tensioning would have taken place during servicing. This failure would allow the Exact arm to swing freely with gravity. No injuries have been reported to-date. Only Type 01 elbow motors are subject to these potential failures, Type 02 elbow motors are not affected.
Remedy Action:-Until Varian inspects the OBI Exact arms, users should not extend or retract the kV Source arm when it is above a patient. Users should ensure that the gantry is positioned so that the kV Source is lateral to, or underneath, the patient-couch prior to extending or retracting the arm. -A Varian Medical Systems Customer Support Service representative will arrange a site visit to check the belt tension of the Type 01 elbow motors of all OBI and MV Exact arms. If overtensioned belts are detected, the elbow motor will be replaced with a Type 02 elbow motor.
Athorized Representative/Importer/Distributor:Varian Medical Systems
Report Source:NCMDR
Source Ref. Number:6243CFE3FC353
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian Medical.pdf