FDANovember 19, 2014device
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.
What to do
FDA enforcement status: Terminated
Brands named
siemens medical solutionssiemenssiemens medical
Recall history
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