Events

Recall of Device Recall GammaMed software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical 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
    35717
  • Event Risk Class
    Class 2
  • Event Number
    Z-1399-06
  • Event Initiated Date
    2006-05-01
  • Event Date Posted
    2006-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46880
  • 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 treatment system - Product Code JAQ
  • Reason
    Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. there is a hazard when entering the treatment plans manually that the user neglects to change the default step size and/or the origin or accidentally enters incorrect parameters.
  • Action
    The recalling firm notified healthcare practitioners using the medical device by letter on 4/17/06 and continuing through 5/1/06. The notification was flagged as a 'Medical Device Recall' and instructed users to adjust system parameters in the autoexec.bat file. The notification further recommended using the identified treatment plans and that manual input should be used for QA purposes only.

Device

Device Recall GammaMed software
  • Model / Serial
    GammaMed ''12it'' serial numbers: GM00213 GM00218 GM00219TB GM00215 GM00202 GM00216 GM00217 GM00212 GM00219TA GM00219 GM00210 GM00214 GM0213
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for the GammaMed model 12it radionuclide applicator system.
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems
  • Manufacturer Address
    Varian Medical Systems, 700 Harris Street, Suite 109, Charlottesville VA 22903-4584
  • Source
    USFDA