Events

Recall of VARiS Version 6.6

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems 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
    35886
  • Event Risk Class
    Class 2
  • Event Number
    Z-1375-06
  • Event Initiated Date
    2005-09-20
  • Event Date Posted
    2006-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47095
  • 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
    A software anomaly may occur which can lead to patient treatment with the wrong field. the anomaly is reported only to occur when this software version (6.6.5022) is used with elekta or siemens linear accelerators .
  • Action
    On 09/20/2005, Varian Medical Systems issued a notification letter via certified mail and FedEx. These letters were issued with instructions on what to do regarding the corrections. Varian Medical Systems intends to release new, updated software.

Device

VARiS Version 6.6
  • Model / Serial
    H462074, H462000, H462003, H462004, H462005, H462006, H462011, H462012, H462013, H462014, H462015, H462016, H462017, H462018, H462019, H462020, H462021, H462022, H462023, H462024, H462025, H462026, H462027, H462028, H462029, H462031, H462040, H462045, H462047, H462048, H462049, H462050, H462051, H462052, H462054, H462055, H462057, H462059, H462060, H462061, H462064, H462065, H462066, H462067, H462068, H462072, H462073, H462075, H462076, H462077, H462079, H462082, H462083, H462084, H462085, H462086, H462087
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to 34 consignees, located in AZ, CA, MA, MI, NC, PA in the USA, and in Australia, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Lithuania, Spain, Sweden, and the United Kingdom
  • Product Description
    Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

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