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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00822-3
Product Name/Description Digital Linear Accelerators fitted with X-ray Volume Imaging (XVI)

Machine Range: 105345 to 151675 (inclusive),
ARTG Number: 111760
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 14/08/2012
Responsible Entity Elekta Pty Ltd
Reason/Issue Elekta Digital Linear Accelerator Gantry Base wheel bolts have been found to become loose and fail in some instances.
Recall Action Recall for Product Correction
Recall Action Instructions Elekta is informing customers that all gantry base wheel bolts should be checked and they should be replaced if found to be showing signs of fatigue.
Contact Information 02 8907 1800 - Elekta Regulatory Affairs