Events

Recall of Varian brand CSeries Clinacs and Acuity, Exact Couch Top

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
    56349
  • Event Risk Class
    Class 2
  • Event Number
    Z-1003-2011
  • Event Initiated Date
    2010-04-19
  • Event Date Posted
    2011-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93281
  • 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 product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails.
  • Action
    Varian issued via customer technical bulletin on April 19, 2010, to Varian Sales, Marketing and Service organization. Notification. The bulletin identified the product, the problem, and the action to be taken by the customer. Customers were asked to fill out the attached form and send it to their local Varial Medical Systems Field Service Office. For questions regarding this recall call 650-483-3153.

Device

Varian brand CSeries Clinacs and Acuity, Exact Couch Top
  • Model / Serial
    Product Codes: H690002, H694936,   H696287, H695791,   H694466, H696406,   H694937, H697423,   H695540,   H695617,   H695747,   H695780,   H696166
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Japan only
  • Product Description
    Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: || H69, Product is manufactured and distributed by: Varian Medical Systems Inc., 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