Events

Recall of 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
    66600
  • Event Risk Class
    Class 2
  • Event Number
    Z-0281-2014
  • Event Initiated Date
    2013-10-23
  • Event Date Posted
    2013-11-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122696
  • 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
    Radiation Therapy Treament Planning System - Product Code MUJ
  • Reason
    Ray search laboratories found an issue with the dose calculation for elekta motorized wedges in ray station 3.0, 3.5 and 4.0. the error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
  • Action
    Medical Device Correction Letters dated 10/23/13 were e-mailed to the user accounts on 10/23/13.

Device

RayStation
  • Model / Serial
    Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.
  • Product Description
    Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB