Device 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.
Z-0984-2015
Product summary
- Event
- Event 69880
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-0984-2015
Official wording
Reason: There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.
Code information: Model number: 08139789, serial numbers: 5419, 5784, 5830
Distribution pattern: US Distribution to the states of UT, WI, and NY.
Derived failure modes
-
Device software or design
Software issue