FDA-Device2015-03-25Class II
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.
Siemens Medical Solutions USA, Inc
Hazard
There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.
Sold states
US Distribution to the states of UT, WI, and NY.
Affected count
3
Manufactured in
51 Valley Stream Pkwy, Malvern, PA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0984-2015Don't want to check this manually?
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