Events

Recall of EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical Systems, Inc, Palo Alto, CA 94304.

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
    28300
  • Event Risk Class
    Class 2
  • Event Number
    Z-0582-04
  • Event Initiated Date
    2004-02-06
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31559
  • 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, Applicator, Radionuclide, Remote-Controlled - Product Code JAQ
  • Reason
    Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy.
  • Action
    The recalling firm notified end users by letters flagged 'Urgent Medical Device Correction' on 2/2/04. The notification reminds users to verify the decay factor before patient treatment. The letter also advises that instrument software be be updated commencing March 2004.

Device

EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufact...
  • Model / Serial
    Serial numbers (Domestic units): 724 215 765 210 212 217 218 214 767 213 743 706708 784 727 795 710 899 702 898 820 219 750 757 894 799 852 821 216 788 202 873 786 896 797 826 709 889 848
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to end users in the United States and internationally.
  • Product Description
    EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader, manufactured by Varian Medical Systems, Inc, Palo Alto, CA 94304.
  • Manufacturer
    Varian Medical Systems

Manufacturer

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