4D Integrated Treatment Console (4DITC), version 8.1 SP2 to 10.1 SP1 의 안전성 경고

Safety alert

2011-08-18

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20110819.html

Field safety notice: 4d integrated treatment console (4ditc), version 8.1 sp2 to 10.1 sp1 medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning 4d integrated treatment console (4ditc), version 8.1 sp2 to 10.1 sp1. 4d itc is designed to assist in providing radiation treatment for patients. there are circumstances in which the 4ditc may be involved in a failure to correctly record treatment history information. the majority of the issues experienced fall into one of three general categories: communication issues between the clinac sub-systems and the 4ditc. communication issues between the 4ditc and the oncology information system (ois). unplanned shut down of the 4ditc or the clinac during treatment. according to the manufacturer, the root cause is related to software design deficiency. varian has scheduled for a mandatory upgrade of the 4ditc to version 10.2 in order to address the above issues. varian also supplemented that the device has been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.