Radiation Therapy Treatment Planning System software 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.
Hazard
An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images
What You Should Do
The firm, RaySearch Laboratories, distributed a "Field Safety Notice, Medical Device Correction #7106" notice dated May 29, 2015,and reply forms to their customers via email. The notice describes the product, problem and actions to be taken. The Customers were provided a workaround as a temporary fix. Customers were also instructed to educate all users, inspect your product and identify all installed units, confirm you have read and understood the notice by contacting Quality and Regulatory Affairs Manager; and complete and return the reply form via email to freddie.cardel@raysearchlabs.com or by fax to 888-501-7195. The solution will be resolved in the next version of RayStation, scheduled for release in June 2015. Customers were advised to share the notice to all those who need to be aware within the organizations. Customers can contact Quality and Regulatory Affairs Manager at +46 8 510 530 12 or via email at david.hedfors@raysearchlabs.com.
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Products
- Brand
- RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden
- UPC
- software build numbers are 4.7.0.15 or 4.7.1.10
Units Affected
20 devices