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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00920-1
Product Name/Description Eclipse Treatment Planning System, (radiation therapy treatment planning system). Versions: 8.9 and 10

Product Code: H48

Multiple serial numbers affected

ARTG Number: 119983
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 7/09/2012
Responsible Entity Varian Medical Systems Australasia Pty Ltd
Reason/Issue When the clock on the Eclipse client workstation is running behind the clock on the Database/System server, it is possible that a change to the assigned HU value for a structure dose not invalidate the density image stored in the cache, and for the subsequent dose and Monitor Unit calculation to be based on the outdated HU assignment. The resultants MUs may be higher or lower than expected. treatment of the patient using these values can lead to under or overdosing.
Recall Action Recall for Product Correction
Recall Action Instructions Varian is providing users with work around instructions and will be providing a technical correction to permanently correct the issue when available.
Contact Information 1800 657 036 - Varian Oncology Helpdesk