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
    74750
  • Event Risk Class
    Class 2
  • Event Number
    Z-0079-2017
  • Event Initiated Date
    2016-05-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148383
  • 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
    For a treatment plan consisting of multiple beam sets, the table for roi plan dose statistics in the report may show the statistics for a beam set dose. the error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.
  • Action
    On May 19th, 2016, RaySearch Laboratories distributed Field Safety Notice, Medical Device Correction notices and reply forms to their customers via email. Actions to be taken by the customer include: 1) Inspect all report templates that are intended to be used for plans with multiple beam sets. 2) Make sure that POI Dose statistics (Plan) is included immediately before ROI Dose statistics [Plan dose] in the Report content area. 3) Please educate planning staff and all users about this workaround. 4) Inspect your product and identify all installed units with the above software version number. Finally, complete and return the reply form via email to: freddie.cardel@raysearchlabs.com or by fax to: 888-501-7195 to confirm that you have read and understand the information. Customers with questions can contact David Hedfors via email: david.hedfors@raysearchlabs.com

Device

Device Recall RayStation
  • Model / Serial
    5.0.0.37, 5.0.1.11 and 5.0.2.35
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, FL, MT, NC NY, TX, OH & WA
  • Product Description
    Radiation Therapy Treatment Planning System, Model 5.0
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB