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
    36555
  • Event Risk Class
    Class 2
  • Event Number
    Z-0194-2007
  • Event Initiated Date
    2006-08-31
  • Event Date Posted
    2006-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48895
  • 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
    linear accelerator - Product Code IYE
  • Reason
    The chain holding the device gantry in position may break.
  • Action
    On 8/31/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.

Device

Device Recall Clinac
  • Model / Serial
    Serial numbers H272325, H291060, H271879, H273040, H272187, H272434
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, England, Taiwan, Switzerland, Sweden, South Korea, Portugal, Poland, Norway, New Zealand, Netherlands, Malaysia, Japan, Italy, Germany, France, Denmark, Czech Republic, Colombia, China, Canada, Belgium, Australia and Venezuela.
  • Product Description
    Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D EX) and 2300 C, C/D EX)
  • 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