Events

Recall of Siemens SimView NT and SimView NT with IDI

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
    69601
  • Event Risk Class
    Class 2
  • Event Number
    Z-0235-2015
  • Event Initiated Date
    2014-10-10
  • Event Date Posted
    2014-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131032
  • 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
    System, simulation, radiation therapy - Product Code KPQ
  • Reason
    Siemens became aware of a very rare occurrence where an intended movement of the simview nt simulation system components could not be stopped with usual hand control commands or by use of the collision detection functionality. it is possible that simulation system components could collide with patient and/or system equipment.
  • Action
    Customers were initially notified about the issue by letter on January 7, 2014 (this action was reported as Z-0786-2014 which has been terminated). Siemens promised to notify them when a fix became available. Customer letter, dated November 7, 2014, was sent to notify end users that a fix has become available and Siemens would contact them to schedule an appointment for the correction.

Device

Siemens SimView NT and SimView NT with IDI
  • Model / Serial
    Model numbers: 5496992, 5497016   with Serial numbers: 6035, 6080, 6029, 6032, 6019, 6001
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of PA, KY, LA, MA, MI, and CA; and countries of: Argentina, Belarus, Bulgaria, Costa Rico, P.R. China, Curacao, Egypt, Repulic Korea, Germany, Greece, Hungary, Italy, Iraq, Jordan, Malaysia, Palestanian Ter, Poland, Thailand, Turkey, and Vietnam.
  • Product Description
    Siemens SimView NT and SimView NT with IDI simulation system components: || Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA