Events

Recall of Device Recall Siemens SIMIView 3000, SIMVIEW NT and MEV ASIM S 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
    48655
  • Event Risk Class
    Class 2
  • Event Number
    Z-2196-2008
  • Event Initiated Date
    2008-03-10
  • Event Date Posted
    2008-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71815
  • 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
    The firm sent an update instruction, "th003/08/s" for motion enable switch/holder assembly. the switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result.
  • Action
    On June 25, 2008 all consignees were notified via written letter and on-site visit by the firm's sales representative, informing them that the switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result and providing instructions on the recall. A new software version will be provided. For assistance contact Siemens at 1-925-246-8407.

Device

Device Recall Siemens SIMIView 3000, SIMVIEW NT and MEV ASIM S systems
  • Model / Serial
    All codes.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide and Nationwide
  • Product Description
    Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems; || Part Number: 5488460; Product is manufactured and distributed by || Siemens Medical Solutions, Oncology Care System, || 4040 Nelson Ave, Concord CA || The product is indicated for use in Radiation therapy simulation.
  • 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