Events

Recall of Segmented Cervix Applicator

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

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
    63667
  • Event Risk Class
    Class 2
  • Event Number
    Z-0607-2013
  • Event Date Posted
    2012-12-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114525
  • 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
    The guide tube which is part of the segmented cervix applicator set is difficult to disconnect from cervical sleeve.
  • Action
    The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION - URGENT FIELD SAFETY NOTICE" letter dated September 28, 2012 to all affected consignees/Customers. The letter identified the affected product, description of problem and recommended user actions to be taken. The consignees/customers were instructed to immediately remove all affected guiding tubes from clinical use, and sequester the components for pending return to Varian Brachy Therapy. Consignees/Customers were requested to complete the attached proof of notification form and return it to Varian Medical Systems. For questions contact-AT&T; international direct dialing network (http://www.business.att.com/bt/dial_guide.isp. Then after hearing the AT&T; signature noise, and. "Please enter the number you are calling", dial 800-360-7909; UK:+44 1293-601-327 or US:+1-434-979-1540. To submit a support request or general inquiry, compose an email with a blank subject line to: brachyhelp@varian.com.

Device

Segmented Cervix Applicator
  • Model / Serial
    Lot L33, Serial numbers H64Y009-GM, H64A056, H640576, H600272, H640784, H640774, H640764, H600603, H640547.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - U.S. state of Georgia and the countries of Canada, Germany, India, Poland, and Thailand.
  • Product Description
    Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves || The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy.
  • Manufacturer
    Varian Medical Systems, Inc.

Manufacturer

Varian Medical Systems, Inc.
  • Manufacturer Address
    Varian Medical Systems, Inc., 700 Harris St Ste 109, Charlottesville VA 22903-4584
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA