Events

Recall of Device Recall COMPASS SW Version 3.1, Catalog Number CS10100

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
    70545
  • Event Risk Class
    Class 2
  • Event Number
    Z-1212-2015
  • Event Initiated Date
    2015-02-02
  • Event Date Posted
    2015-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134007
  • 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, linear, medical - Product Code IYE
  • Reason
    Error in the software. during internal tests of the current development version of the compass sw it was found that dose reconstruction for dmlc plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.
  • Action
    IBA sent an Field Safety Notice dated January 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Please do not use the dose reconstruction function COMPASS 3.1 and 3.1a for DMLC plans from Monaco or Eclipse -11 when the jaws move or MLC leaves reverse during beam on. A correct Version ( COMPASS 3.1b) will be delivered as soon as it is available. The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on February 2, 2015. Should you have questions or require additional information, please contact the Customer Service Team at South and Middle America, USA and Canada - Phone. +1 901.386.2246 Asia Pacific, Australia and New Zealand - Phone. +86 10 8080 9107 All other countries - Phone. 49 9128 607 - 38

Device

Device Recall COMPASS SW Version 3.1, Catalog Number CS10100
  • Model / Serial
    Model : SW Version 3.1  Lot or Serial Number : n.a
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of AZ and OK., and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, North and South America, Mexico, Brazil, Venezuela, Colombia, Panama, Asia, China, Japan, Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, Malaysia and Guam.
  • Product Description
    COMPASS SW Version 3.1, 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