Events

Recall of Device Recall Interplant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Computerized 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
    58228
  • Event Risk Class
    Class 2
  • Event Number
    Z-2622-2011
  • Event Initiated Date
    2008-12-01
  • Event Date Posted
    2011-06-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98759
  • 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
    Interplant software: if the trajectory needle with a non-zero retraction is adjusted in any of the planning views (transverse, 3d) and the program is closed and reopened, the needle definitions page in the dose plan summary (plan view) displays the needle with a 0.00 retraction even when the needle is displayed correctly in the planning view. if the eliminate leading spacers function is applied t.
  • Action
    Computerized Medical Systems, Inc. sent a "CUSTOMER ADVISORY" letter dated December 1, 2008, to all affected customers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to discontinue use of the product. There is no workaround at this time. This issue was resolved in Interplant Release 3.4.1 software. All possibly affected users have been shipped the Interplant Release 3.4.1 software in May 2010. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.

Device

Device Recall Interplant
  • Model / Serial
    Interplant Release 3.4.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including states of: CA, KS, KY, MA, MD, ME, MO, NC, NE, NY, OH, PA, TX and VA and countries of: Australia, Brazil, Chile, China, Germany and Japan.
  • Product Description
    Interplant Radiation Treatment Planning System, Interplant Release 3.4.0 || Used when planning and performing prostate brachytherapy implant procedure. It provides ultrasound probe alignment and radioactive seed implantation.
  • Manufacturer
    Computerized Medical Systems Inc

Manufacturer

Computerized Medical Systems Inc
  • Manufacturer Address
    Computerized Medical Systems Inc, 13723 Riverport Drive, Suite 100, Maryland Heights MO 63043
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA