Events

Recall of Device Recall ARTISTE MV with Artiste Digital Linear Accelerators

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., Concord, CA.

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
    57704
  • Event Risk Class
    Class 2
  • Event Number
    Z-1422-2011
  • Event Initiated Date
    2010-12-03
  • Event Date Posted
    2011-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97050
  • 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
    The firm become aware of a potential issue with artiste system that may result in patient injury should the positioner belt break, and the cam disc (secondary safety mechanism) is not installed and if the flat panel is over the patient.
  • Action
    The firm, Siemens, issued a "Customer Information" letter on December 3, 2010 via mail to all its direct consignees/customers. The letter described the product, problem and actions taken by the firm to the customer. Siemens arranged for an inspection of their customers systems to make sure the safety mechanism is fully functional. Siemens instructed the customers to include the Customer Information letter in their ARTISTE System Owner manual chapter 'Safety Advisory Letters' . If you any questions, please call 925-246-8407.

Device

Device Recall ARTISTE MV with Artiste Digital Linear Accelerators
  • Model / Serial
    Serial No. 5647 - 5718  (Specifically 5647,5651,5652,5660,5657, 5664,  5654,5686,5687,5688,5689, 5606,  5690,5700,5701,5699,5704,5705,5707,5708,  5714, 5716, and 5718)
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution.
  • Product Description
    Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel Positioner; Part No. 8139789; || Intended use: To deliver x-ray radiation for therapeutic treatment of cancer. || Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA; and Siemens Medical Solutions AG, Roentgenstrasse, Kemnath, Germany, and Siemens Medical Solutions AG, Henkestrasse, Erlangen, Germany
  • Manufacturer
    Siemens Medical Solutions USA, Inc., Concord, CA

Manufacturer

Siemens Medical Solutions USA, Inc., Concord, CA
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., Concord, CA, 4040 Nelson Ave, Concord CA 94520-1200
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA