Events

Recall of Device Recall RayAutoplan, aka tRayAutoplan, commercial name (TomoTherapy) SharePlan

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
    63110
  • Event Risk Class
    Class 2
  • Event Number
    Z-2378-2012
  • Event Initiated Date
    2011-05-30
  • Event Date Posted
    2012-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112573
  • 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
    This field notice concerns two behaviors of the shareplan (multiple fraction groups and depth offset) that may be unexpected and are not clearly described in the user manual. none of these behaviors have caused patient mistreatment or other incidents. however, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivere.
  • Action
    RaySearch Laboratories sent an Urgent Field Safety Notice Medical Device Correction dated May 30, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consigness were instructed to completely avoid affecting the erroneous behaviour, verify in TomoTherapy Hi-Art that the plans sent to TomoTherapy SharePlan 1.1 only have one single fraction group with a single fraction size,used for all fractions, and do not attempt to import treatment plans having more than one fraction size into the product. To completed avoid affecting the erroneous behaviour the user can either offset the measured curves before importing them into beam commissioning or add the depth offset tothe calibration depth. For further information consigness should contact RaySearch Laboratories AB Quality and Regulatory Affairs at +46 722 366 110 or the Tomo Therapy support at support@tomotherapy.com. North America 1 866 368 4807 Belgium 0800 38783 France 0805 631 565 Germany 0800 000 +541 Italy 800-986 399 Netherlands 0800 0201364 Spain 800 3000049 Switzerland 0800 001927 UK 0868 238 6035 China/Northern 10 800 712 1701 China/Southern 10800 120 1701 Hong Kong 800 967912 Japan 0044 22 132374 Singapore 800 1204683 South Korea 0079 81 4800 7204 All other locations + 1 608 824 2900 or +32 2 40 44 44

Device

Device Recall RayAutoplan, aka tRayAutoplan, commercial name (TomoTherapy) SharePlan
  • Model / Serial
    SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10).
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, KY, MI, NY, OK, and OR. Internationally to Canada, Belgium, United Kingdom, Australia, France, Germany, and Poland.
  • Product Description
    The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. || Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists
  • Manufacturer
    RAYSEARCH LABORATORIES AB

Manufacturer

RAYSEARCH LABORATORIES AB