Events

Recall of 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
    66724
  • Event Risk Class
    Class 2
  • Event Number
    Z-0438-2014
  • Event Initiated Date
    2013-10-23
  • Event Date Posted
    2013-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123181
  • 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
    A safety risk regarding a potentially existing dark current radiation phenomenon on the linear accelerator (linac) in combination with imrt or marc (rotational imrt) treatments using unflat (flattening filter free) beams. in case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value.
  • Action
    Siemens sent an Urgent Medical Device Correction letter dated October 23, 2013 including the release of update instruction TH024/13/S to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.

Device

ARTISTE Linear Accelerator
  • Model / Serial
    Serial Numbers:  5364, 5419, 5640, 5737, 5823, 5830, 5166, 5342, 5416, 5444, 5479, 5485, 5628, 5745, 5746, 5762, 5763, 5764, 5772, 5781, 5783, 5797, 5815, 5819, 5820, 5822, 5829, 5837, 5839, 5888, 5896, 5911, 5937
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA (nationwide) including states of: FL, NC, NY, PA, TN, UT, and WI; and countries of: Angola, Brazil, Canada, P.R. China, Germany, India, Japan, Republic Korea, Poland, and Thailand.
  • Product Description
    SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, 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