Events

Recall of ARTISTE or ONCOR Linear Accelerators in combination with 160MLC

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
    58637
  • Event Risk Class
    Class 2
  • Event Number
    Z-2404-2011
  • Event Initiated Date
    2011-04-15
  • Event Date Posted
    2011-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99754
  • 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
    Siemens became aware of a potential safety risk related to the behavior of the 160 mlc when using the "motion stop" button followed by "reset" several times during the treatment of one beam or one segment.
  • Action
    Siemens sent a Consumer Safety Advisory and Urgent Medical Device Correction letter to all affected customers beginning on April 15, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Updated instructions for using the Motion Stop button with the 160-MLC were provided with the letter. Customers were requested to use the Motion Stop button and the corresponding reset procedure only when required. In the unlikely event that the Motion Stop button needs to be used repeatedly during treatment of the same beam or segment, customers were advised to perform an "in session resumption of the beam by selecting 'abort' at the syngo RT Therapist and then re-selecting the beam again for the remaining delivery. In this case, the beam will be re-loaded with the originally prescribed leaf positions. Please consider the already delivered dose for resumption. Customers were asked to include the Customer Advisory Notice in their LINAC System Owner Manual in chapter 'Safety Advisory Letters' where it should remain until the measures defined above were performed. Customers were asked to inform all affected personnel immediately.

Device

ARTISTE or ONCOR Linear Accelerators in combination with 160MLC
  • Model / Serial
    Product Model Number ARTISTE MV System 8139789 ONCOR Avant Garde 5863472  ONCOR Impression 5857920 ONCOR Impression Plus 5857912 ONCOR Expression 7360204 and 7360717
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, DE, FL, IL, KY, LA, MA, MI, NE, NJ, NY, OH, PA, SD, TN, UT, WI, and WV.
  • Product Description
    ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator). Linear Accelerators that may be affected are: || ARTISTE MV System; || ONCOR Avant Garde || ONCOR Impression || ONCOR Impression Plus || ONCOR Expression. || Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany; || Registered by Siemens Medical Solutions, Concord, CA. || ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
  • 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