Events

Recall of Device Recall M19 (Iridium 192)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Source Production & Equipment 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
    52428
  • Event Risk Class
    Class 2
  • Event Number
    Z-1717-2009
  • Event Initiated Date
    2008-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82955
  • 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
    Source, brachytherapy, radionuclide - Product Code KXK
  • Reason
    Radioactive source broke during use.
  • Action
    Source Production and Equipment, Inc. notified the Distributor by phone and letter March 2008 and requested the return of all affected units.

Device

Device Recall M19 (Iridium 192)
  • Model / Serial
    OSI A011, OSI A010, and OSI A015.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- GA, NV and NY.
  • Product Description
    M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. || Brachytherapy source.
  • Manufacturer
    Source Production & Equipment Inc

Manufacturer

Source Production & Equipment Inc