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
    76342
  • Event Risk Class
    Class 2
  • Event Number
    Z-1815-2017
  • Event Initiated Date
    2017-01-18
  • 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=152867
  • 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
    An error in nvidia gpu (graphics processing unit) card drivers can occur for certain software programs. in a non-standard citrix environment where the gpu settings are configured with a virtual citrix graphics board (graphics card) an erroneous calculation may be allowed.
  • Action
    RaySearch Laboratories sent a Field Safety Notice dated January 18, 2017, to their customers via email. ACTIONS TO BE TAKEN BY THE USER include: 1) Verify the GPU settings on each of the Citrix XenApp servers according to the instructions in this section. A correct configuration of the RayStation GPU settings will show a graphics board that has been verified by RaySearch. The graphics boards that are verified for operation are listed in the section "Graphics card (GPU) for accelerated computations" in the System Environment Guidelines. 2) Check that displayed graphics board in the GPU Settings dialog is listed as verified for operation according to the section "Graphics card (GPU) for accelerated computations" in the System Environment Guidelines. The following figure shows an example of a correct installation. If the graphics board is not verified for operation according to the System Environment Guidelines, the installation is incorrect. In this case, disable GPU computation and contact RaySearch Support. 3) Check if "Citrix Systems Inc. Display Driver" is displayed instead of the graphics board name. If so, the Citrix XenApp installation is incorrect. If an incorrect installation of Citrix XenApp is detected: a. Set the Citrix XenApp server to maintenance mode or disable GPU computation on the erroneous server; b. Contact RaySearch Support for instructions on how to resolve the issue. Customers are advised to pass a copy of the safety notice and educate IT staff and all users that are members of the RayStation-Administration user group (or equivalent) about this (i.e., users with the permission to change GPU settings). Inspect your product and identify all installed units with the above software version number(s), then confirm you have read and understood this notice by completing and returning the last page via email or fax to: freddie.cardel@raysearchlabs.com, fax 888 501 7195.

Device

Device Recall RayStation
  • Model / Serial
    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, 5.0.2.35
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, LA, MN, MD, MA, MI, MS, MT, NJ, NY, NC, NV, OH, OK, OR, PA, RI, TN, TX, VA, VT, VI, WA, WI, and Washington D.C.
  • Product Description
    Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 || 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
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB