Events

Recall of Device Recall Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0

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
    67535
  • Event Risk Class
    Class 2
  • Event Number
    Z-1481-2014
  • Event Initiated Date
    2014-02-14
  • Event Date Posted
    2014-04-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125690
  • 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
    Raysearch laboratories has recalled "raysearch ray station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on ct-image.
  • Action
    RaySearch Laboratories sent a Field Safety Notice, Medical Device Correction letter dated February 14, 2014 to their customers via email. The letter identified the affected product, problem and actions to be taken by the user. Customers with questions may contact Freddie Cardel, Director of Customer Support at 1-877-778-3849 or via email at freddie.cardel@raysearchlabs.com.

Device

Device Recall Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0
  • Model / Serial
    Versions: 2.0.0.15, 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of: AZ, CA, CT, CO, DE, FL, IL, NJ, NY, MA, MD, MS, OH, PA, TN, VA and WA. and the countries of Australia, New Zealand, Belgium, New South Wales, Republic of Korea, Italy, Germany, China, France, Switzerland, Netherlands, Spain, Austria, United Kingdom and Norway.
  • Product Description
    RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB