Events

Recall of Device Recall Theratron 1000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MDS Canada Inc. DBA MDS Nordion.

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
    35617
  • Event Risk Class
    Class 2
  • Event Number
    Z-1180-06
  • Event Initiated Date
    2004-07-08
  • Event Date Posted
    2006-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46575
  • 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
    System, Radiation Therapy, Radionuclide - Product Code IWB
  • Reason
    The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions.
  • Action
    A User Bulletin (CUB-2004-01dated 7/5/04) was issued to affected users on 8/24/04 and 8/31/04. The bulletin provided 2 options for corrective action.

Device

Device Recall Theratron 1000
  • Model / Serial
    Model Theratron 1000
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to medical facilities in FL and KS. The product was also shipped to Kuwait, Spain, Honduras, Romania, France, Grrece, Bangladesh, Germany, Nepal, Canada, England, Thailand, Phillippines, Mexico, Columbia, India, Switzerland, Syria, Trinidad & Tobago, Ireland, Turkey, Algeria, Portugal, Poland, Iran, China, Cuba, Belgium, Hungary, Egypt, Italy, Vietnam, Sri Lanka, and Costa Rica.
  • Product Description
    Theratron 1000 Cobalt Radiotherapy
  • Manufacturer
    MDS Canada Inc. DBA MDS Nordion

Manufacturer

MDS Canada Inc. DBA MDS Nordion
  • Manufacturer Address
    MDS Canada Inc. DBA MDS Nordion, 447 March Road, Kanata Canada
  • Source
    USFDA