Events

Recall of Device Recall Varian High Energy Linear Accelerator

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
    58976
  • Event Risk Class
    Class 2
  • Event Number
    Z-2764-2011
  • Event Initiated Date
    2011-05-18
  • Event Date Posted
    2011-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100758
  • 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
    Accelerator, Linear, medical - Product Code IYE
  • Reason
    The coolant system input water supply manifold may leak in some clinac linear accelerators, posing a risk of electrical shock to any person working within the protective housing.
  • Action
    Varian Medical Systems, Inc. Oncology Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 18, 2011, via certified mail, return receipt requested. The letter identified the product, problem and recommended actions to be taken. The letter states that customers will be contacted by Varian Service to arrange for replacement of the recalled product. For additional information contact Varian Medical Systems, Inc at 888- 827-4265.

Device

Device Recall Varian High Energy Linear Accelerator
  • Model / Serial
    Model numbers H14, H27 and H29. Serial numbers: H140012 H140889 H140900 H140910 H140920 H140766 H140890 H140901 H140911 H140921 H140809 H140891 H140902 H140912 H140923 H140815 H140892 H140903 H140913 H140924 H140838 H140893 H140904 H140914 H140925 H140851 H140895 H140905 H140915 H140926 H140876 H140896 H140906 H140916 H140927 H140886 H140897 H140907 H140917 H140929 H140887 H140898 H140908 H140918 H140930 H140888 H140899 H140909 H140919 H140932 H270817 H271430 H271893 H272242 H290255 H271038 H271435 H271932 H272246 H290415 H271105 H271447 H271949 H272323 H291177 H271198 H271462 H271961 H272396  H271201 H271516 H271975 H272400  H271214 H271521 H271991 H272423  H271250 H271618 H272107 H272445  H271280 H271761 H272125 H272480  H271302 H271843 H272140 H290034  H271311 H271889 H272238 H290192
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and countries of: Australia, Columbia, Denmark, France, Ireland, Italy, Japan, Morocco, Poland, Portugal, Saudi Arabia, South Korea, Spain, and United Kingdom.
  • Product Description
    Clinac Linear Accelerator; || Model numbers H14, H27 and H29. || Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
  • 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