Events

Recall of Device Recall Linear Medical Accelerator ARTISTE MV system

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
    53054
  • Event Risk Class
    Class 2
  • Event Number
    Z-1064-2011
  • Event Initiated Date
    2009-07-30
  • Event Date Posted
    2011-02-08
  • 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=84556
  • 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
    Potential for mistreatment-- when treatment plans intended for non-artiste machinese are loaded, if the plans contain unspecified beam parameters, attributes or unknown block codes, the therapy system may remove those parameters.
  • Action
    The firm,Siemens, sent two Customer Advisory letters (TH004/09/S and TH008/09/S) contained in the Update Instructions to all consignees/customers with active devices. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to follow the updated instructions. Siemens service representative will sign a document noted as CORRECTED upon completion of the software installation. If you have any questions, call 1-925-602-8157.

Device

Device Recall Linear Medical Accelerator ARTISTE MV system
  • Model / Serial
    Artiste MV system Part Number 8139789. RT Therapist Part Number 8162815, Therapist Express Basic part number 8151289. Optional parts: Syngo RT Therapist assist part number 8162807, Therapist Express Assist part number 8151297.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Germany, France, Poland, Norway, Australia, Malaysia, Spain, New Zealand, the UK, India, Republic of Korea, Canada, Ireland, Italy, Egypt, Belgium, Philippines, Saudi Arabia, Netherlands, Hungary, Norway and South Africa.
  • Product Description
    Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Therapist Express Basic, syngo RT Therapist Assist or Therapist Express Assist workspace with software version NET VA10A for RTT 4.1.122 or NET V10B for RTT 4.1.125, manufactured by Siemens Medical Solutions, Concord, CA. || Intended use: 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