Events

Recall of Device Recall ARTISTE Linear Accelerator

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
    56345
  • Event Risk Class
    Class 2
  • Event Number
    Z-0449-2011
  • Event Initiated Date
    2010-01-22
  • Event Date Posted
    2010-11-24
  • 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=93277
  • 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 robotic lift armature shaft may break and allow the flat panel positioner with the digital flat panel imager to fall into the flat panel cradle. if the positioner is over a patient, there is a potential for injury.
  • Action
    Siemens sent an Urgent Medical Device Correction letter to all on January 27, 2010, via phone, Fax, certified mail and/or delivery via Siemens Customer Service Group to all its direct consignees, informing them of the affected products, the problem, and provided instructions on the recall. Consigneees were to be contacted by an ARTISTE Service Representative for an appointment for corrective action. Consignees were instructed to include Customer Safety Advisory Notice in their ARTISTE System Owner Manual. For questions regarding this recall call (925) 246-8407.

Device

Device Recall ARTISTE Linear Accelerator
  • Model / Serial
    All units--Dates of manufacture: July 17, 2008 to September 19, 2008.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, DE, FL, LA, MA, MI, MO, NC, NE, NJ, OH, PA, TN, UT, WI, AND WV and Egypt, Germany, Japan, Lebanon, Malaysia, New Zealand, Poland, Russia, Spain, Sweden, and Turkey
  • Product Description
    Siemens brand ARTISTE MV, Artiste Digital Linear Accelerators in combination with the Flat Panel, Part No. 8139789, || To deliver x-ray radiation for therapeutic treatment of cancer. || Product is manufactured and distributed by Siemens Medical Solutions, Concord, CA
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 757 Arnold Dr Ste A, Martinez CA 94553-3615
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA