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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01278-1
Product Name/Description XiO versions 4.50 and higher (Radiation therapy treatment planning system)

ARTG Number: 99769
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 29/11/2013
Responsible Entity Elekta Pty Ltd
Reason/Issue When computing the Effective Depth (with bolus) to the weight point during treatment planning, XiO could use the bolus density for a particular segment of the weight fan when it should be using the CT density. If the CT density is different than the bolus density, the effective depth will be incorrect which will lead to incorrect dose. The problem occurs when the computation of the bolus polygon incorrectly invades the patient contour and overlaps an area where the CT density is much different than bolus density. When the dose is computed along each fanline/depthline, an area of bolus-patient overlap is detected, the incorrect density could be assigned. There is a remote probability of a mistreatment resulting in serious injury.
Recall Action Recall for Product Correction
Recall Action Instructions Elekta is advising users that if all fractions are bolused, a workaround would be to scan the patient with the bolus in place. The incorrect assignment of density to areas of bolus-patient overlap was introduced in XiO Release 4.50.00 and will be resolved in Patch Release 4.80.03 and release 5.00.01. Patch Release 4.80.03 is now available (ie, Jan 2014) and release 5.00.01 is expected to be available by March 2014. This action has been closed-out on 11/02/2016.
Contact Information 02 8907 1800 - Elekta Regulatory Affairs