Events

Recall of Device Recall Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp..

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
    63856
  • Event Risk Class
    Class 2
  • Event Number
    Z-1103-2013
  • Event Initiated Date
    2012-12-10
  • Event Date Posted
    2013-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114917
  • 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
    Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from xknife using dicom-rt.
  • Action
    Integra initiated a voluntary recall on December 10, 2012 by providing a written Urgent: Medical Device Recall Notification to US consignees who have experienced the software issue due to the configuration of their system. The letter identifies the affected product, as well as, advises customers of the nature of the issue and how it affects treatment records. - Advises customers that they will be contacted when V 5.0.3 software, where the software error has been addressed, is available to schedule an upgrade. - Requests that customer consignees complete and return the Product Recall Acknowledgment Form. If customer have additional questions, they should contact the firm's service hotline at 1-888-772-7378.

Device

Device Recall Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning
  • Model / Serial
    Software Versions 5.0.1 and 5.0.2.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
  • Product Description
    Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, || Software Versions 5.0.1 and 5.0.2. || Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.