Events

Recall of Device Recall ARTISTE MV System, LInear Accelerator (LINAC)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69880
  • Event Risk Class
    Class 2
  • Event Number
    Z-0984-2015
  • Event Initiated Date
    2014-11-19
  • Event Date Posted
    2015-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131894
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • Reason
    There may be an existing dark current phenomenon on artiste linac in combination with imrt or marc treatments using unflat beams. software issue.
  • 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.

Device

Device Recall ARTISTE MV System, LInear Accelerator (LINAC)
  • Model / Serial
    Model number: 08139789, serial numbers: 5419,  5784,  5830
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of UT, WI, and NY.
  • Product Description
    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
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA