Recall of Device Recall Siemens

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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 - Product Code IYE
  • Reason
    The range of tolerance is to high for the accessory holder, therefore, wedges and other accessories do not latch to the locking mechanism correctly.
  • Action
    On 12/20/08, the firm issued letters via certified mail to direct consignees, informing them of the affected product and providing instructions on the recall. Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for additional information.


  • Model / Serial
    All units of Part Number: 8139789
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide and Worldwide
  • Product Description
    Artiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manufactured by Siemens Medical Solutions, Oncology Care System, Concord, CA || Medical charged-particle radiation therapy system.
  • Manufacturer


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