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Terminated

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.

FDA Recall Z-0984-2015 · Posted 2015-03-18

Recall StatusTerminated
Product CodeIYE
Date Initiated2014-11-19
Date Terminated2015-04-28
Product Quantity3

Reason for Recall

There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mARC treatments using unflat beams. Software issue.

Firm Action

Siemens Planned Action: 1. Providing recommendations for user actions in terms of routine dosimetric quality control checks for any IMRT treatment at very high dose rates (Multiple X) as well as for mARC treatments. 2. Software update for the Function Controller #3, which controls parts of the beam generation. This software update enables the correct switching between Pulse Forming Network (PFN) and reduced Pulse Forming Network (iPFN) in pause state, to reduce the dark current during the movement as much as possible. This software will be installed by a Siemens service representative. 3. Siemens will contact the user to make an appointment to implement the modification system at a date and time when the system will be available. These corrections shall be made free of charge. The deployment of the permanent correction shall be completed by July 1, 2015. For further questions please call (610) 219-6300.

Root Cause

Software design

Distribution Pattern

US Distribution to the states of UT, WI, and NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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