Events

Recall of VARiS 6.2, 6.1 and 6.0

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
    53461
  • Event Risk Class
    Class 2
  • Event Number
    Z-0133-2010
  • Event Initiated Date
    2009-09-15
  • Event Date Posted
    2009-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85562
  • 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
    Software issue: under certain circumstances, when a therapy treatment field is transferred to varis vision 6.2, 6.1 and 6.0 via link procedures, the rotation direction will be reversed.
  • Action
    Recall initiated September 15, 2009. An "Urgent - Field Safety Notice" letter was distributed to all affected users, with a description of the problem and corrective action steps. The letter was also distributed to Varian sales, marketing, and service organizations, informing them of the issue. For further information in the USA and Canada, contact Varian at 1-650-424-5731 or 1-888-VARIAN5 (888- 827-4265). In Europe, contact +41 41 749 8844.

Device

VARiS 6.2, 6.1 and 6.0
  • Model / Serial
    Codes H850008, H850904, H851353, H851333, H880033, H850907, H851388, H881354, H850078, H850912, H851674, H881389, H850110, H850920, H851838, H881392, H850129, H850930, H851992, H881393, H850130, H850962, H852053, H881410, H850211, H850963, H852544, H881482, H850217, H850964, H852546, H881483, H850258, H850965, H880004, H881484, H850322, H850967, H880012, H881515, H850345, H850968, H880098, H881524, H850350, H850969, H880221, H881557, H850451, H851020, H880449, H881576, H850474, H851025, H880699, H881586, H850555, H851032, H880720, H881641, H850616, H851059, H880734, H881642, H850686, H851080, H880809, H881658, H850696, H851087, H880862, H881671, H850739, H851091, H881033, H881839, H850759, H851132, H881037, H881865, H850788, H851138, H881060, H881895, H850830, H851145, H881102, H881951, H850831, H851252, H881205, H881993, H850861, H851290, H881207, H882003, H850877, H851327, H881220, H882049, H882623, H885074
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution to 100 consignees throughout the US in IL, NY, MI, NJ, AL, TN, MD, OH, FL, and TX, and to Brazil, Chile, China, Czech Republic, Egypt, Germany, Hungary, Israel, Italy, Japan, Malaysia, the Netherlands, Romania, Slovakia, Slovenia, South Korea, Spain, Taiwan, Thailand and the United Kingdom.
  • Product Description
    VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Manufactured by Varian Medical Systems, Palo Alto, CA.
  • 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