Events

Recall of SharePlan 1.1

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
    63186
  • Event Risk Class
    Class 2
  • Event Number
    Z-2444-2012
  • Event Initiated Date
    2011-10-10
  • Event Date Posted
    2012-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112869
  • 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 notice concerns behavior of the shareplan that may be unexpected and not clearly described in the user manual. this behavior has not 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 delivered treatment. the behavior appears, when importing rfa-files (.Asc).
  • Action
    RaySearch Laboratories sent an Urgent Field Safety Notice Medical Device Correction letter dated October 10, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. To completely avoid effects of the erroneous behaviour, RFA-file has to be modified to have the crossline profiles sgtored in the X column of the file and the inline profiles in the Y column. Upon request, RaySearch Laboratories will provide help to the customers by transferring the RFA-files to the correct format through a scrip. Customers were instructed to pass on the notice to all those who need to be aware within their organization and to maintain awareness on this notice until the new labeling version has been received to ensure effectiveness of the corrective action. For questions regarding this recall call +46 8 54 50 61 42.

Device

SharePlan 1.1
  • Model / Serial
    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, OR, SD, and WI. Internationalyl to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and United Kingdom.
  • Product Description
    SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan || 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