Events

Recall of Device Recall SIMVIEW 3000 and SIMVIEW NT with CT option or 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
    50480
  • Event Risk Class
    Class 2
  • Event Number
    Z-0646-2009
  • Event Initiated Date
    2008-11-06
  • Event Date Posted
    2009-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75465
  • 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
    Radiation Therapy Simulation System - Product Code KPQ
  • Reason
    Excessive wear on drive belts used for image intensifier and/or x-ray head drive mechanisms may result in uncontrolled movement, which may cause injury.
  • Action
    Firm has reissued the Urgent Medical Device Customer Letter regarding the belt replacement and a reminder message to replace the belts yearly during the annual Preventative Maintenance. The letter requests that customers follow the guidelines, which consist of making any required SAD adjustments utilizing the Image Intensifier drive, the X-Ray Head Drive, or both; being vigilant of any change in the type or level of noise from either of the drive belt assemblies while they are in use as this may be an indication of wear; discontinuing clinical operation if there is any doubt, and contacting their local Siemens Service organization to inspect the belts. Currently, the firm is distributing the current belt kit to replace the entire installed base of active SIMVIEW Simulators (3000 and NT models).

Device

Device Recall SIMVIEW 3000 and SIMVIEW NT with CT option or IDI.
  • Model / Serial
    all drive belts in SIMVIEW 3000 and NT with model numbers 1957153, 1957161, 5496992, 5497016, 5496984.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI. || Radiation therapy simulation system.
  • 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