Events

Recall of Device Recall Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems 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
    53045
  • Event Risk Class
    Class 2
  • Event Number
    Z-2231-2009
  • Event Initiated Date
    2009-07-17
  • Event Date Posted
    2009-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84536
  • 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 treatment planning system - Product Code MUJ
  • Reason
    Software issue/mistreatment potential-- due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.
  • Action
    Varian Medical Systems Recall initiated on July 17, 2009. A product notification letter was distributed to the affected user, with a description of the problem and user corrective action steps. The letter will be distributed to the sales, marketing and service organizations via certified mail. A software correction is planned.

Device

Device Recall Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48
  • Model / Serial
    Model number H48, code number H484023.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to one user in Texas
  • Product Description
    Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system.
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

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