Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 3/25/2015
Class lI:
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. Recall Number Z-0984-2015
REASON
There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue..
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 11/19/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
3
DISTRIBUTION
US Distribution to the states of UT, WI, and NY.
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