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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00652-3
Product Name/Description Eclipse Treatment Planning System (Radiation treatment planning system); Version 8.5, 8.6, 8.9, 10 & 11

Multiple Serial Numbers affected

Product Code: H48

ARTG Number: 119983
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 2/07/2012
Responsible Entity Varian Medical Systems Australasia Pty Ltd
Reason/Issue A software anomaly has been identified with the Eclipse Treatment Planning System where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimisation, the Monitor Units and dose distribution may not reflect the intended prescription.
Recall Action Recall
Recall Action Instructions Varian is recommending users to implement work around instructions until a software fix is developed and implemented.
Contact Information 1800 657 036 – Varian Oncology Helpdesk