Important Safety Alerts

Important Safety Alerts

Field Safety Notice: Elekta XVI 4.5 and 4.6

19 Oct 2011

Medical device supplier, Elekta Ltd, issued an important notice to bring users attention to certain precautionary measures required for the operation of Elekta XVI.

XVI Dual Registration can inform customers if an organ at risk has moved in relation to the target since the planning stage of treatment. It was discovered at customer site that there is a software error leading to compromise of the Dual Registration, and this issue applies to release 4.5 and 4.6.

An Important Notice A357 was sent out to all XVI 4.5 and 4.6 users. The notice informs customers using Dual Registration with compromise how to recognize the issue and avoid it. A later software release of XVI will give a solution to this problem.

According to the local supplier, the affected products have been distributed to Hong Kong. If you are in possession of the affected products, please contact your supplier for necessary actions.

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