Events

Recall of Device Recall Clinac

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
    38048
  • Event Risk Class
    Class 2
  • Event Number
    Z-1074-2007
  • Event Initiated Date
    2007-05-02
  • Event Date Posted
    2007-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52851
  • 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
    Medical Linear Accelerator - Product Code IYE
  • Reason
    The wedge tray may slip out of the clinac interface mount during gantry rotation.
  • Action
    The firm sent out a Product Notification Letter on 5/2/07 to customers who have ordered this guide block through a Varian Service Center. A Varian Field Engineer will visually inspect guide blocks at-site that have been installed from Service stock for all affected customers, and replace if necessary.

Device

Device Recall Clinac
  • Model / Serial
    Serial numbers: H271877 H271036 H290175 H290157 H290215 H180257 H180534 H271708 H180236 H180534 H271708 H271947 H271096 H290541 H271321 H180811 H290305 H272102 H180044 H271340 H271067 H270755 H271043 H271671 H270518 H270864 H271228 H271645 H271118 H271603 H270704 H180230 H290272 H271264 H270471 H272116 H271531 H271233 H270486 H271062 H271091 H271344 H180449 H271371 H180410 H270237 H290227 H290218 H180562 H271758 H270472 H271830 H180484 H270763 H270733 H271930 H290149 H271552 H270819 H270628 H271079 H271673 H270546 H290348 H271871 H273089 H271070 H271649 H180510 H290203 H290228 H290189 H290219 H271521 H271150 H180440 H270533 H180284 H271154 H180542 H270429 H180239 H290300 H271133
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed and manufactured between 1999 and 2006. Distributed worldwide, including USA, Ecuador, Columbia, Taiwan, Austrailia, Austria, Brazil, Canada, Chile, China, Finland, France, Germany, India, Italy, Japan, New Zealand, Poland, Portugal, Serbia and Montenegro, Singapore, Spain, Switzerland, UAE, and UK.
  • Product Description
    Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C;/D, Clinac 2100 C, C/D & EX and Clinac 2300 C &C;/D
  • 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