Events

Recall of Radionics Head and Neck Localilizer (HNL), Version B

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radionics, 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
    29219
  • Event Risk Class
    Class 2
  • Event Number
    Z-1020-04
  • Event Initiated Date
    2004-05-25
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33343
  • 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, Planning, Radiation Therapy Treatment - Product Code MUJ
  • Reason
    Software may provide inaccurate coordinates and cause mistreatment.
  • Action
    Radionics notified users by telephone and follow-up letters dated 5/25/04 via facsmile. Users are requested not to use the system. A corrected software will be issued.

Device

Radionics Head and Neck Localilizer (HNL), Version B
  • Model / Serial
    Serial Numbers: 032610023, 0326100023, 32690010, 041200023
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Canada, Germany, Greece
  • Product Description
    Radionics Head and Neck Localilizer (HNL), Version B
  • Manufacturer
    Radionics, Inc.

Manufacturer

Radionics, Inc.
  • Manufacturer Address
    Radionics, Inc., 22 Terry Ave, Burlington MA 01803-2516
  • Source
    USFDA