Events

Recall of Siemens

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
    61578
  • Event Risk Class
    Class 2
  • Event Number
    Z-1494-2012
  • Event Initiated Date
    2012-04-04
  • Event Date Posted
    2012-05-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108458
  • 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 became aware of a potential issue with siemens-branded oncor or primus linear accelerator with an optivue or mvision imaging system that has the potential collision problem of the imaging panel if the panel does not retract before the gantry rotates; this may result in patient injury.
  • Action
    Siemens sent an Update Instruction containing the Customer Information letters beginning April 4, 2012 delivered by Siemens customer Service Group or by certified mail to all affected customers. The letter identified the affected product, what is the issue and what has Siemens done to address this issue. The letter instructs customer to include this Customer Information in their Digital Linear Accelerator System Owner Manual chapter Safety Advisory Letters where it should remain.

Device

Siemens
  • Model / Serial
    All units of these models.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Product Description
    Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging system; || Model Numbers: ONCOR Expression 7360717, ONCOR Impression Plus 5857912, ONCOR Avant Garde 5863472, PRIMUS HI 4504200; || ARTISTE/ONCOR/PRIMUS systems are manufactured by: || SIEMENS AG, MEDICAL SOLUTIONS, || Roentgenstrasse 19-21, || Kemnath, GERMANY 95478 || Product Usage: || Medical charged-particle radiation therapy system. The intended use of the SIEMENS branded 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, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA