Events

Recall of ARTISTE MV Systems

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
    52723
  • Event Risk Class
    Class 2
  • Event Number
    Z-1888-2009
  • Event Initiated Date
    2009-04-09
  • Event Date Posted
    2009-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83817
  • 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
    Unexpected treatment plan alteration-- software issue may result in unintended modifications to treatment.
  • Action
    Siemens Medical Solutions USA, Inc. notified consignees of the affected product by advisory letter via Certified Mail on April 09, 2009. For further information, contact Siemens Medical Solutions at 1-925-602-8157.

Device

ARTISTE MV Systems
  • Model / Serial
    All Product with Part Number 8139789 (RT Therapists are part of the system).
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (MA, UT, OH, NJ, NE, FL, OH, MI and PA), Germany, Poland, the UK, Ireland, Italy, France, South Korea, and Belgium.
  • Product Description
    ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with Software version NET VA10A for RTT4.1.122 or RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. || Medical charged-particle radiation therapy system.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA