Events

Recall of GammaMed 12i Accessory

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems, Inc. Oncology 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
    60231
  • Event Risk Class
    Class 2
  • Event Number
    Z-0330-2012
  • Event Initiated Date
    2011-10-06
  • Event Date Posted
    2011-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104834
  • 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 product models 1 & 2 have a design flaw problem where the clamping adapter can obstruct movement of the source cable in the event the bronchial catheter is dislodged from the connector.
  • Action
    Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION LETTER/FIELD SAFETY NOTICE" letter dated October 6, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Contact the Varian Help Desk at 1-888-827-4265 for questions regarding this notice.

Device

GammaMed 12i Accessory
  • Model / Serial
    CODES:   H630164 ,H630703 ,H630727 ,H630756 ,H630787 ,H630810 ,H630829 ,H630850 ,H630868 ,H630888 ,H630165 ,H630705 ,H630728 ,H630757 ,H630789 ,H630811 ,H630832 ,H630851 ,H630869 ,H630889 ,H630168 ,H630706 ,H630729 ,H630758 ,H630790 ,H630812 ,H630833 ,H630852 ,H630870 ,H630891 ,H630170 ,H630711 ,H630732 ,H630760 ,H630792 ,H630813 ,H630834 ,H630854 ,H630871 ,H630892 ,H630205 ,H630712 ,H630733 ,H630764 ,H630793 ,H630814 ,H630835 ,H630855 ,H630872 ,H630895 ,H630206 ,H630713 ,H630736 ,H630769 ,H630794 ,H630815 ,H630837 ,H630857 ,H630877 ,H630896 ,H630210 ,H630714 ,H630737 ,H630771 ,H630795 ,H630817 ,H630839 ,H630858 ,H630878 ,H630897 ,H630211 ,H630716 ,H630739 ,H630774 ,H630798 ,H630818 ,H630841 ,H630859 ,H630879 ,H630898 ,H630214 ,H630718 ,H630741 ,H630776 ,H630801 ,H630820 ,H630842 ,H630860 ,H630880 ,H630901 ,H630215 ,H630719 ,H630744 ,H630777 ,H630802 ,H630822 ,H630843 ,H630863 ,H630881 ,H630902 ,H630216 ,H630720 ,H630747 ,H630778 ,H630804 ,H630825 ,H630845 ,H630864 ,H630884 ,H630903 ,H630219 ,H630721 ,H630749 ,H630781 ,H630807 ,H630826 ,H630847 ,H630866 ,H630885 ,H630904 ,H630701 ,H630722 ,H630753 ,H630784 ,H630809 ,H630828 ,H630848 ,H630867 ,H630886
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide).
  • Product Description
    Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00264, Model 2-H63; Product is distributed by Varian Medical Systems Inc., Palo Alto, CA and Manufactured by Varian Medical Systems Haan GmbH, || Bergische Strasse 16, D-42781 Haan, Germany. || The Varian Medical System GammaMed Afterloader system is a remotely controlled intelligent robotic device intended to be used to deliver high dose-rate radiation therapy, in close proximity to and from within diseased tissues. Palliative care and treatments with curative intent to both benign and non-benign disease using interstitial, intracavitary, intraluminal, intra and inter-operative brachytherapy or combinations of any these treatment types are possible using this device.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Manufacturer Address
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA