Events

Recall of Device Recall Varian Medical Systems VARiS

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
    29471
  • Event Risk Class
    Class 2
  • Event Number
    Z-1314-04
  • Event Initiated Date
    2004-06-24
  • Event Date Posted
    2004-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33805
  • 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, Planning, Radiation Therapy Treatment - Product Code MUJ
  • Reason
    A malfunction in the software of the varis versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a non-varian machine and a varian machine and a non-varian field is loaded in the treatment session.
  • Action
    Notification letter to consignees sent 06/14/2004.

Device

Device Recall Varian Medical Systems VARiS
  • Model / Serial
    Version Numbers 6.2.27 and 6.2.35, 510k number K001643, serial numbers H8__ (31901, 50044, 50149, 50181, 50187,50260, 50284, 50315, 50357, 50397, 50430, 50804, 50873, 51096, 51152, 51186, 51082, 51463, 51534, 51580, 51658, 51773, 51787, 59032, 59040, 59041, 59045)
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    produt was distributed to 28 medical facilities, 12 in the United states, 16 foreign
  • Product Description
    medical device and software systems
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc
  • Manufacturer Address
    Varian Medical Systems Inc, 3100 Hansen Way, Palo Alto CA 94304-1028
  • Source
    USFDA