Events

Recall of Device Recall iba COMPASS SW Version 3.0

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Iba Dosimetry Gmbh.

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
    66808
  • Event Risk Class
    Class 2
  • Event Number
    Z-0456-2014
  • Event Initiated Date
    2013-08-20
  • Event Date Posted
    2013-12-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123519
  • 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
    Accelerator liner medical - Product Code IYE
  • Reason
    The development partner of iba informed that there is problem in a sw component used in compass when converting region of interest (roi) geometries to dose grid representation. under certain conditions this problem generates too large roi voxel volumes causing erroneous dose statistics and dvhs.
  • Action
    Iba sent an Field Safety Notice on August 20, 2013, by email and letter delivered by UPS, Please distribute this notice to all those who need to be aware within your area of responsibility where the affected software have been installed (e.g. colleagues, satellites). Please maintain awareness of this notice and resulting action until we have provided you with a new software version. We would kindly ask you to acknowledge the receipt of this Field Safety Notice. Please sign and send back the attached Confirmation of Receipt within four weeks after the receipt of this Field Safety Notice. We deeply apologize for the inconvenience. We are working on a new software version with corrected functionality. This should become available during next fall and we will ship it to you as soon as it is released, together with the installation and verification instructions. Should you have questions or require additional information, please contact the Customer Service Team at: Service Department IBA Dosimetry GmbH Bahnhofstrasse 5 DE-90592 Schwarzenbruck, Germany Tel.:+49 9128 607 38 Fax: + 49 9128 607 26 Email: service@iba-group.com .

Device

Device Recall iba COMPASS SW Version 3.0
  • Model / Serial
    SW Version 3.0. Catalong Number CS10-100
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of CT, MA, OH, CA, SC, NY and OK, and the countries of International distribution (from Germany) Poland, Germany, GB, The Netherlands, Spain, Turkey, Canada, Mexico, China, Hong Kong and Singapore.
  • Product Description
    iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) || radiological
  • Manufacturer
    Iba Dosimetry Gmbh

Manufacturer

Iba Dosimetry Gmbh
  • Manufacturer Address
    Iba Dosimetry Gmbh, Bahnhofstr. 5, Schwarzenbruck Germany
  • Manufacturer Parent Company (2017)
    Ion Beam Applications SA
  • Source
    USFDA