Events

Recall of Device Recall Flexible Probe with Blocking Washer

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
    59913
  • Event Risk Class
    Class 2
  • Event Number
    Z-0282-2012
  • Event Initiated Date
    2010-05-20
  • Event Date Posted
    2011-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103990
  • 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
    Flexible Probe - Product Code JAQ
  • Reason
    The instructions for use ( ifu) distributed with product prior to 2004 lacks the correct limit to the sterilization cycles and checks regarding the firm seating of the blocking washer.
  • Action
    Varian Medical Systems sent a Medical Device Recall (PNL-GM-42697-2) in May 2010 for the blocking washer on the flexible probe, Varian part number GM11002420, a component of the Segmented Cylinder Applicator Set. The letter was to inform users that a flexible probe with an unstable or shifted blocking washer must not be used due to the potential for treatment length error. The blocking washer may move from rough handling or sterilization. Users were told to discard any instances of the obsolete Instructions for Use (IFU) in use and replace it with the IFU (PGM11004150 4 March 24, 2010.pdf). A Receipt Verification Card was included requesting consignees to fill out, fax or e-mail immediately to Varian BrachyTherapy.

Device

Device Recall Flexible Probe with Blocking Washer
  • Model / Serial
    Lot number Y01 to E19
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, Germany, Belgium, Canada, Mexico City, Spain, Brazil, Switzerland, Uzbekistan, India
  • Product Description
    Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the Segmented Cylinder Set, GM11004150)
  • 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