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Siemens Medical Solutions USA, Inc recalls ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System line
Recalled March 25, 2015 · FDA recall Z-0984-2015 · Siemens Medical Solutions USA
Hazard
There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue. · FDA Class II
Units
3
Sold at
US Distribution to the states of UT, WI, and NY.
Description
There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.
Product
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →