FastPlan treatment planning system 의 안전성 경고

Safety alert

2012-03-20

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120320b.html

Field safety notice: varian fastplan treatment planning system medical device manufacturer, varian medical systems (varian), has issued a field safety notice concerning fastplan treatment planning system. according to varian, an anomaly has been identified with the ct localization module of the fastplan treatment planning system. if the module reports a significant difference in tilt or spin on a slice (compared to the average of all slices) and the user elects to “discard” that slice, an incorrect calculation of the isocenter location may result. if this issue goes undetected, the reported coordinates of the isocenter will be incorrect and a mistreatment could result. varian is notifying all possibly affected customers with a field safety notice. according to varian, the affected devices were distributed to hong kong. if you are in possession of the products, please contact your supplier for necessary actions.