Events

Recall of Device Recall Varian

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems, Inc. Oncology Systems.

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
    62562
  • Event Risk Class
    Class 2
  • Event Number
    Z-2153-2012
  • Event Initiated Date
    2012-07-02
  • Event Date Posted
    2012-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111025
  • 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
    A software anomaly has been identified with the import export application version 11.0 where mlc leaf positions for plans using brainlab m3 and mmlc are incorrectly imported.
  • Action
    Varian Medical Systems sent a " Urgent Medical Device Correction Urgent Field Safety Notice" dated July 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed until a correction is deployed all treatment plans using the BrainLab m3 mMLC must be imported using the Import Wizard only. Varian Medical Systems is developing a technical correction for this issue. You will be contacted by a Customer Service Representative when this correction is available to schedule its installation on your system. For further questions please call 1.888.827.4265.

Device

Device Recall Varian
  • Model / Serial
    Serial Numbers/CODES: HIT0535, HIT2953
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of New York and Ohio.
  • Product Description
    Varian brand Varian ARIA Oncology Information System, Import Export || application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Manufacturer Address
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA