Events

Recall of Device Recall Clinac C series

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
    35728
  • Event Risk Class
    Class 2
  • Event Number
    Z-1206-06
  • Event Initiated Date
    2006-06-06
  • Event Date Posted
    2006-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46694
  • 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
    Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.
  • Action
    The firm has initiated recall by sending its consignees a product notification letter 06/06/2006, and intends to dispatch service representatives to perform necessary modifications.

Device

Device Recall Clinac C series
  • Model / Serial
    All lots
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers included. Model numbers 2100, 2100C/D, 21 EX. 2300 C/D, 23 EX, 600C, 600 C/D, 2500 C, Trilogy, 6EX and Silhouette.
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc
  • Manufacturer Address
    Varian Medical Systems Inc, 911 Hansen Way, Palo Alto CA 94304
  • Source
    USFDA