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
    67511
  • Event Risk Class
    Class 2
  • Event Number
    Z-1308-2014
  • Event Initiated Date
    2014-02-06
  • Event Date Posted
    2014-03-31
  • 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=125643
  • 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 Treatment Planning System - Product Code MUJ
  • Reason
    Raysearch laboratories has recalled raysearch ray station 4.0 software due to clinical dose calculation errors during radiation therapy.
  • Action
    On February 6, 2014, RaySearch Laboratories distributed Urgent Medical Device Correction notices to their customers via email regarding the affected product. To determine if the version you are using is affected, bring up the About box in the RayStation application and check if the number reported is "4.0.2.9". If so, the notice applies to your version. Customers are advised to inform all planning staff and all users about the instructions listed on the notice. Customers are advised to inspect their system and identify all installed units with the referenced software version numbers listed on the notice. Corrective labeling is distributed to the customers in the form of the safety notification attached to this report and the software problem will be resolved in RayStation patch 4.0.3 scheduled for market release end of February 2014 and in all future releases. For further information and return of the reply form, please contact: Freddie Cardel, Director of Customer Support, RaySearch Americas, (877) 778-3849 or freddie.cardel@raysearchlabs.com.

Device

Device Recall RayStation
  • Model / Serial
    Model#: 4.30; Version: 4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,
  • Product Description
    RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB