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
    78900
  • Event Risk Class
    Class 2
  • Event Number
    Z-0380-2018
  • Event Initiated Date
    2017-07-17
  • 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=160827
  • 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 the proton qa preparation module in raystation 6 (including sp1 and sp2), if the snout position or gap is modified in the qa module, the dose in the qa module may be computed for a different setup than what is used for qa measurements. this could result in an incorrect dosage being provided to a patient.
  • Action
    Ray Search sent a Field Safety Notice letter dated July 14, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter included a response form with instructions for workarounds until the software is corrected.

Device

Device Recall RayStation
  • Model / Serial
    6.0.0.24 , 6.1.0.26 , 6.1.1.2 or 6.2.0.7
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.
  • Product Description
    RayStation || Product Usage: 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.
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB