RT Chart function of ARIA 의 안전성 경고

Safety alert

2011-09-08

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20110908.html

Urgent field safety notice: rt chart function of aria™ medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning rt chart function of aria™. according to varian, the issue is related to the use of the rt chart function in aria™, versions 8.0 and 8.1. when users select the “convert to setup field” option, a set-up field is created, that removes the dmlc (dynamic multi leaf collimator) plan components in order to create an open collimator for field light setup purposes. in a recently reported case, a user, having selected this option in error, then converted the setup field back to a treatment field. the resulting treatment field is then missing the dmlc. if this error is not detected prior to patient treatment, open field treatment can result. this issue is caused by software design limitation. varian recommends the users to perform the following actions: if you accidentally select the “convert to setup field” option, and have not pressed “save”, you can select the “reload all” button and refresh the previous data. if you accidentally select the “convert to setup field” option, and have pressed “save”, you should recreate or re-import the mlc file or treatment field in question before proceeding. follow pre-treatment plan qa program for imrt plans established in your clinic, to ensure plan validity. varian is notifying potentially affected customers and developing a service pack to modify the system behavior to prevent this accidental removal of the dmlc plan components. once available, the affected customers will be contacted by a varian service representative to schedule installation in the system. noted that, users of rt chart function aria™, version 8.2 or greater is unaffected by this fsn. according to the local supplier, hk is affected by this field safety notice and the local supplier has informed the affected parties. if you are in possession of the affected product, please contact your supplier for necessary actions.