Artis Q systems with s/w version VD11 and Gigalix X-Ray tubes 의 리콜

Recall

RC-2016-RN-01475-1

Class II

2016-11-10

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01475-1

For artis systems with software version vd11, and gigalix x-ray tubes, the semi-automatic focus switch may in cases of a type of defect in foci “small” and “micro” (if present), does not work as intended when pressing the footswitch multiple times. this focus defect, that causes the failure of the semi-automated focus switch, becomes more likely as the service life of the x-ray tube increases.This can result in the spontaneous malfunction of the active (micro or small) focal spot and a loss of imaging. while the manufacturer is not aware of any patient injuries, under the above circumstances this issue can cause a loss of the fluoroscopy functionality and may lead to a situation where the clinical procedure has to be aborted, rescheduled or the patient needs to be relocated to a functioning system.

A software update will correct the above mentioned issue. After the update, the Artis system will switch again semi-automatically to a functioning focal spot for all focus defects, enabling images to be displayed until the current procedure comes to an end. Users are advised that: - For system operation with a 2-foci Gigalix X-Ray tube, it is still possible to perform image acquisition with the large focus after manual selection of a corresponding organ program. - For system operation with a 3-foci Gigalix X-Ray tube, fluoroscopy is still possible with the "small" or "micro" focus that is still intact through manual selection of a corresponding fluoro program. In addition, image acquisition with the large focus is still possible. - There should be standard emergency procedures in place in case of system failures.