Events

Recall of Device Recall Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems

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
    65418
  • Event Risk Class
    Class 2
  • Event Number
    Z-1663-2013
  • Event Initiated Date
    2013-05-29
  • Event Date Posted
    2013-07-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118861
  • 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 information regarding the film mode calibration may have been considered difficult to interpret when translated. siemens healthcare cr / radiation oncology had become aware that this issue may have resulted in mistreatment of patients.
  • Action
    Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION" letter and Update instruction TH022/13/S beginning on May 29, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. July 19, 2013 - TH023/13/S was distributed is now in progress. This is the FILM Mode Physics Primer Addendum.

Device

Device Recall Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Li...
  • Model / Serial
    All customers who use the BEAMVIEW for position verification imaging on Siemens MEVATRON series, PRIMART (limited release) PRIMUS and/or ONCOR or ARTIST Linac Systems.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA Nationwide and countries of: Algeria, Angola, Argentina, Austria, Australia, Bahamas, Belgium, Bosnia Herzeg, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hungary, India, Indonesia, Italy, Iran, Iraq, Ireland, Japan, Jordan, Kenya, DPR of Korea, Kosovo, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Pakistan, Palestinian Ter, Peru, Philippines, P.R. China, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, Sri Lanka, South Africa, Sweden, Switzerlan, Taiwan, Thailand, Trinidad Tobago,Turkey, United Kingdom, Venezula, Vietnam, Rep of Yemen, and Zambia.
  • Product Description
    Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. || The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is 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, 757 Arnold Dr Ste A, Martinez CA 94553-3615
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA