Events

Recall of Device Recall RayStation

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
    61269
  • Event Risk Class
    Class 2
  • Event Number
    Z-1317-2012
  • Event Initiated Date
    2011-12-06
  • Event Date Posted
    2012-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107694
  • 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
    An issue was found with the dose calculation in the raystation 2.0, that could result in a potential overestimation of the dose. this could lead to the potential under-dosage of a patient.
  • Action
    The firm decided to recall and sent Urgent Field Safety Notice Medical Device Correction letters to consignees on 12/06/2011. The letters described the issue, identified the affected product, actions to be taken by the user, a solution, and contact information. Users are to follow the two part workaround, and educate their staff and all users on the workarounds. The letter states that the issue will be resolved in the next version of RayStation. If further information is needed, users are to contact either Freddie Cardel, Director of Customer Support, RaySearch Americas, at 1-877-778-3849 or freddie.cardel@raysearchlabs.com; or Niclas Borglund, Director of Service, RaySearch Laboratories AB, at 46-8-5450-6130 or niclas.borglund@raysearchlabs.com

Device

Device Recall RayStation
  • Model / Serial
    Software version and build number is 2.0.0.15. Model number RayStation 2.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of FL, MA, NJ, and NY and the country of the Netherlands.
  • Product Description
    RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. || RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com || Designed for treatment planning and analysis of radiation therapy.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB