ExacTrac 5.x Patient Positioning System 의 안전성 경고

Safety alert

2013-04-09

2013-04-09

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130409.html

Medical device safety alert: brainlab exactrac 5.X patient positioning system medical device manufacturer, brainlab ag, has issued a field safety notice concerning exactrac 5.X patient positioning systemversions 5.0 and 5.5 (v. 5.0, 5.0.1, 5.0.2 and v. 5.5, 5.5.1, 5.5.2). there is an anomaly detected in exactrac 5.X when used in combination with anon-brainlab radiation treatment planning system (tps). this anomaly can mislead the user whenselecting a treatment plan / isocenter (radiation treatment target) in exactrac for patient positioning atthe linear accelerator (linac). when using a specific plan update workflow in combination with a non-brainlab tps, there is a possibility in exactrac 5.X to generate an unintended blend of two initially separate plans of the same patient. if the anomaly occurs in exactrac 5.X when using a specific plan update workflow in combination with a non-brainlab tps, such a display of inconsistent positioning information might mislead the user when selecting a treatment plan / isocenter in exactrac for patient positioning. if not detected by the user, this might result in a patient and treatment target position at the linear accelerator (linac) that is different than intended. as a consequence the treatment dose might be delivered to a region different from the intended targetregion. if the deviation would exceed clinically acceptable limits,this could result in ineffectivetreatment, serious patient injury or even death of the patient. the manufacturer will send the field safety notice to all affected users and reminds users to follow the steps as mentioned in the section “user corrective action”. brainlab also advises users to continue to follow the instructions and warnings as described in the user guide. especially relevant are the warnings in the exactrac clinical user guide for reviewing isocenter information regarding plausibility and correctness, before patient positioning and treatment. besides, brainlab will provide a software update to affected customers to solve this issue. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 april 2013.