4D Integrated Treatment Console v8.6 with ARIA RT Chart v8.5, all of 4DITC v8.3 의 안전성 경고

Safety alert

2011-07-26

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20110726.html

Field safety notice: 4d integrated treatment console v8.6 with aria rt chart v8.5, all of 4ditc v8.3 medical device manufacturer, varian, has issued an urgent field safety notice to the customers of 4ditc v8.6 with aria rt chart v8.5, all of 4ditc v8.3. the 4ditc may erratically fail to load the planned wedge without warning or notification when receiving an approved plan from the oncology information system (ois). 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. this errant behavior may occur with the above-affected releases of 4d integrated treatment console, v8.6 or earlier. to avoid the issue, the manufacturer recommended customers to make workflow adjustments in their planning, scheduling, and delivery portions prior to delivering a wedge field treatment. according to the local supplier, hong kong is affected. if you are in possession of the affected product, please contact your supplier for necessary actions.