Eclipse 10 (Client builds 10.0.28 and 10.0.34) 의 안전성 경고

Safety alert

2011-08-29

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20110829.html

Urgent field safety notice: eclipse 10 (client builds 10.0.28 and 10.0.34) medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning eclipse 10 (client builds 10.0.28 and 10.0.34). the issue is that the treatment field energy may change from the current selection to a previous selection without user intervention and without invalidating the mu (monitoring unit) or calculated dose distribution. the energy shown or selected by the treatment planner in the fields tab of external beam planning and in the general tab of field properties may differ from the value actually used for dose calculation. this issue is caused by incorrect handling of the energy mode object within the memory cache system used by eclipse external beam planning version 10. varian recommends the users to observe the followings: do not use multiple sessions in eclipse; always close the patient file in eclipse after completing work on the patient record; always close eclipse fully before opening a new patient. furthermore, users should compare the energy shown in dose section and lmc section (if applicable) of the “errors and warnings from last calculation” log in the calculation tab of the field properties dialog with the energy value shown in the fields tab of external beam planning to detect a discrepancy; and confirm and verify all treatment planning calculations. varian is notifying potentially affected customers and preparing a correction for eclipse version 10 to address this issue. according to the supplier, hk is not affected by this field safety notice. if you are in possession of the affected product, please contact your supplier for necessary actions.