Events

Recall of GammaMed 12it

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
    36304
  • Event Risk Class
    Class 2
  • Event Number
    Z-0487-2007
  • Event Initiated Date
    2006-09-11
  • Event Date Posted
    2007-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48385
  • 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
    radionuclide applicator system - Product Code JAQ
  • Reason
    Medical device for patient treatment does not meet electrical safety standards.
  • Action
    The recalling firm notified end users by e-mail and letter on 09/11/06 and advised that some devices did not comply with electrical safety standards. The firm stated that they plan to make modifications to improve electrical safety performance but users may continue to use the device to treat patients. The notification included a response form for users to fax back verification of receipt.

Device

GammaMed 12it
  • Model / Serial
    H630202
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including NC, GA, IN, IL and AZ in USA, Germany, South Korea, Switzerland, Belgium, and Brazil.
  • Product Description
    GammaMed 12it radionuclide applicator system, Varian Medical Systems, Palo Alto, CA.
  • Manufacturer
    Varian Medical Systems

Manufacturer

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