4d integrated treatment console versions 8.1.3 to 8.8 의 안전성 경고

Safety alert

2012-04-18

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120418b.html

Field safety notice: 4d integrated treatment console (4ditc) versions 8.1.3 to 8.8 medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning 4d integrated treatment console (4ditc) v8.1.3 to 8.8. varian has identified that after a plan with wedge field has been opened in 4d integrated treatment console, users may not notice that the wedge filter may actually be missing from a selected field, and the treatment application will not notify the user of this anomaly and will not prevent beam delivery. the user may come to understand that the wedge filter is missing only after the treatment field has been partially or completely delivered and when the user attempts to close the patient from the treatment application. with this situation the treatment application forces the user to unload the patient, requires user authorization, and informs the user that the treatment record for the missing wedge field will not be saved to the ois. varian supplemented that delivery of a treatment field without the planned and calculated wedge filter could result in an over dosage for that beam and potentially an unintended dose uniformity of the target treatment volume. varian is now notifying all affected customers and providing instructions regarding the use of wedges and secondary channel integrity check (scic) which is a data integrity check to further ensure safety of the radiation beam delivery. in addition, varian will provide a software upgrade to all affected users to correct the problems mentioned above. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.