Brainlab Cranial Navigation System (all versions before Cranial 3.0) 의 리콜

Recall

RC-2015-RN-00558-1

Class I

2015-06-23

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00558-1

Brainlab has detected that, when using the brainlab cranial navigation system, the following may have a significant effect on the overall navigation accuracy: • large distance between reference array and region of interest • major changes of the camera position relative to the reference array during the procedure those instances could potentially intensify small inaccuracies arising from individual steps of the complex navigation procedure. in the worst case scenario, these inaccuracies may cause an inaccurate display of instruments by the navigation system, compared to the actual patient anatomy. if these inaccuracies are not detected by user verification of navigation accuracy as described in the user manual, this could ultimately lead to ineffective treatment, serious injury or even death of the patient.

Brainlab has developed a software update to improve navigation accuracy. Brainlab will contact their customers to arrange for the installation of the update. This action is a follow-up to RC-2013-RN-00397-1. This action has been closed-out on 05/12/2016.