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
    75731
  • Event Risk Class
    Class 2
  • Event Number
    Z-0721-2017
  • Event Initiated Date
    2016-11-09
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151111
  • 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
    Software anomaly; an issue was found with the proton pencil beam scanning (pbs) dose calculation in raystation 4.0, 4.5, 4.7 and 5.0. for treatment plans with a combination of range shifter, large air gap and beams that enter the patient surface at an oblique angle, the dose calculation accuracy may be less than expected.
  • Action
    Ray Search sent an Urgent Field Safety Notice Medical Device Correction letter (dated 11/8/2016) via e-mailed to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Inspect their product and identify all installed units with the above software version number, then confirm you have read and understood this notice (contact information included).

Device

Device Recall RayStation
  • Model / Serial
    Build numbers: 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11 or 5.0.2.35
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of California, Florida, Illinois, Louisiana, Michigan, New Jersey, Tennessee, Texas, Washington
  • Product Description
    RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System || Product Usage: || RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB