Events

Recall of RayStation software version 4.0.3.4

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by RAYSEARCH LABORATORIES AB.

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
    68162
  • Event Risk Class
    Class 2
  • Event Number
    Z-1806-2014
  • Event Initiated Date
    2014-04-25
  • Event Date Posted
    2014-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127076
  • 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
    This notice concerns a problem with the computation of roi voxel volumes for cases where the ct has variable slice spacing. the dose grid volumetric representation of an roi can be wrong. this affects all dose-volume properties for such rois, including dvh, dose statistics, clinical goals and constraints or objective functions. furthermore, if material override rois are used, or if the external is not represented by contours, the bug can trigger an error in the 3d dose distribution.
  • Action
    On April 25, 2014, RaySearch emailed all consignees of the affected product a copy of the recall notice as well as the response forms. Back up notification methods include phone calls and site visits.

Device

RayStation software version 4.0.3.4
  • Model / Serial
    Software version 4.0.3.4
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy, New Zealand, Republic of Korea, Switzerland, Spain, and United Kingdom.
  • Product Description
    RayStation software version 4.0.3.4 || RayStation is a software system designed for treatment planning and analysis of radiation therapy.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB