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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00363-1
Product Name/Description On-Board Imager (OBI) (used with linear accelerators for verification of correct patient position in relation to isocenter and verification of treatment fields)

ARTG Number: 117950
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 26/03/2014
Responsible Entity Varian Medical Systems Australasia Pty Ltd
Reason/Issue In the three known failures, belt over-tensioning caused the motor shaft to fail over time. This over tensioning would have taken place during servicing. This failure permitted the Exact arm elbow joint to swing freely with gravity. A message such as "kV detector elbow axis not calibrated" or "kV source elbow axis not calibrated" may appear, or the user may hear a grinding or shearing sound at or before the time of failure. Potential injury from the kV source striking a patient is dependent upon the anatomic site being treated and the height of the couch.
Recall Action Recall for Product Correction
Recall Action Instructions 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 over-tensioned belts are detected, the elbow motor will be replaced with a Type 02 elbow motor. 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. Sites doing their own servicing or using a third party service provider, must ensure that they are following Varian service instructions. This action has been closed-out on 02/02/2016.
Contact Information 1800 657 036 - Varian Oncology Help Desk